UNK - SCREWS: TRAUMA
Report
- Report Number
- 2939274-2019-59443
- Event Type
- Malfunction
- Date Received
- July 30, 2019
- Report Date
- May 4, 2019
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: OF THE 50 DEVICES REPORTED, 19 DEVICES WERE RECEIVED FOR EVALUATION. ADDITIONAL REPORTED SCREW PART NUMBERS: 259.460: QUANTITY 1;UNK - SCREWS: TRAUMA: QUANTITY 5;396.970: QUANTITY 1;200.810: QUANTITY 1;207.734: QUANTITY 1;207.035: QUANTITY 1;UNK - SCREWS: MATRIXNEURO: QUANTITY 1;400.834.04S: QUANTITY 1;404.820: QUANTITY 1;201.932E: QUANTITY 2;204.830S: QUANTITY 2;04.214.112: QUANTITY 1;400.834S: QUANTITY 3;02.206.226: QUANTITY 1;400.835: QUANTITY 2;04.211.024S: QUANTITY 1;04.130.212S: QUANTITY 1;04.503.226.04S: QUANTITY 2;02.130.118: QUANTITY 1;413.370: QUANTITY 1;214.546: QUANTITY 1;UNK - SCREWS: LOCKING: TRAUMA: QUANTITY 4;201.928: QUANTITY 1;201.932: QUANTITY 1;207.742: QUANTITY 1;207.648: QUANTITY 1;04.005.550: QUANTITY 1;04.118.538S: QUANTITY 1;04.211.020S: QUANTITY 1;04.211.018S: QUANTITY 2;412.112S: QUANTITY 1;207.740: QUANTITY 1;04.503.104.01S: QUANTITY 1;04.503.414.01S: QUANTITY 1. ADDITIONAL REPORTED SCREW LOT NUMBERS: 1L44433; 1L93538; 2L12399; 2L22726; 2L63058; 2L64759; 3L51341; 3L65888; 4L11096; 4L36390; H519968; L017742; L493820; L954463; L971682; 2201980; 3L22834, 3L22795, L993946; H622363; H699984; L312722 ADDITIONAL REPORTED SCREW UDI NUMBERS: ((B)(4). DEVICE CODE: 1069 ¿ BREAK ¿ TOTAL OF 48. METHOD CODE: 10 ¿ ACTUAL DEVICE EVALUATED ¿ TOTAL OF 19. 4114 ¿ DEVICE NOT RETURNED ¿ TOTAL OF 25. RESULT CODES: 3221 ¿ NO FINDINGS AVAILABLE ¿ TOTAL OF 25. 3243 ¿ STRESS PROBLEMS IDENTIFIED ¿ TOTAL OF 12. 3252 ¿ FRACTURE PROBLEM ¿ TOTAL OF 5. 213 ¿ NO DEVICES PROBLEM FOUND ¿ TOTAL OF 1. 3211 ¿ DEFORMATION PROBLEM ¿ TOTAL OF 1. CONCLUSION CODES: 67 ¿ NO PROBLEM DETECTED ¿ TOTAL OF 26. 4307 ¿ CAUSE TRACED TO COMPONENT FAILURE ¿ TOTAL OF 13. 19 ¿ CAUSE TRACED TO USER ¿ TOTAL OF 2. 18 - FAILURE TO FOLLOW INSTRUCTIONS ¿ TOTAL OF 2. 4315 - CAUSE NOT ESTABLISHED - TOTAL OF 1. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. ADDITIONAL REPORTED SCREW LOT NUMBERS: 4L36390, 4L11096. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. ADDITIONAL REPORTED SCREW LOT NUMBERS: 1L93538, 2L12399. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. ADDITIONAL REPORTED SCREW LOT NUMBERS: 2L63058, 3L22834, 3L22795, L993946. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. H6: CODES UPDATED TO IMDRF DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. ADDITIONAL REPORTED SCREW LOT NUMBERS: H519968, H622363. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B5, D1, D4, H1: FOLLOW-UP REPORTS ARE BEING SUBMITTED TO COMPLY WITH FDA DIRECTIVES THAT THERE SHOULD BE ONE PRODUCT CODE PER REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THIS REPORT SUMMARIZES NOE 48 /NOE MALFUNCTION EVENTS INVOLVING A TOTAL OF 50 ACTUAL DEVICES FOR BROKEN SCREWS. TWO EVENTS OCCURRED PREOPERATIVELY, FORTY-THREE EVENTS OCCURRED INTRAOPERATIVELY, AND THREE EVENTS OCCURRED POSTOPERATIVELY BY USE OF A HEALTHCARE PROFESSIONAL. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 15-78 YEARS OLD. PATIENT¿S WEIGHT RANGE: 50 TO 120 KILOGRAMS. GENDER: 10 FEMALE, 10 MALE, AND 28 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 15 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 204 POUNDS. GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD; PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS; GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 41 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 64 KGS. GENDER ¿ 1 FEMALE, 0 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 2 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 1 FEMALE, 0 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 20 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS INVOLVING A TOTAL OF 2 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 4 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 44-45 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 63 - UNKNOWN KGS. GENDER ¿ 1 FEMALE, 1 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 20 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 2 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 0 MALE, AND 2 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 63 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES 5 MALFUNCTION EVENTS INVOLVING A TOTAL OF 5 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 18 - 36 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 1 FEMALE, 0 MALE, AND 4 UNKNOWN.
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 78 YEARS OLD
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS INVOLVING A TOTAL OF 2 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 0 MALE, AND 2 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES NOE 1 NOE MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 55 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 265 POUNDS. GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 3 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 15 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 50 KGS. GENDER ¿ 1 FEMALE, 0 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 65 YEARS OLD PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 51 YEARS OLD. PATIENT¿S WEIGHT RANGE: UNKNOWN KGS. GENDER: 1 FEMALE, 0 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 28 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 1 FEMALE, 0 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 44 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 52 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 1 FEMALE, 0 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS INVOLVING A TOTAL OF 2 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 0 MALE, AND 2 UNKNOWN.
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 52 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN KGS. GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 69 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
OF THE 50 DEVICES REPORTED 11 DEVICES WERE RECEIVED FOR EVALUATION. ADDITIONAL REPORTED SCREW PART NUMBERS: 259.460: QUANTITY 1;UNK - SCREWS: TRAUMA: QUANTITY 5;396.970: QUANTITY 1;200.810: QUANTITY 1;207.734: QUANTITY 1;207.035: QUANTITY 1;UNK - SCREWS: MATRIXNEURO: QUANTITY 1;400.834.04S: QUANTITY 1;404.820: QUANTITY 1;201.932E: QUANTITY 2;204.830S: QUANTITY 2;04.214.112: QUANTITY 1;400.834S: QUANTITY 3;02.206.226: QUANTITY 1;400.835: QUANTITY 2;04.211.024S: QUANTITY 1;04.130.212S: QUANTITY 1;04.503.226.04S: QUANTITY 2;02.130.118: QUANTITY 1;413.370: QUANTITY 1;214.546: QUANTITY 1;UNK - SCREWS: LOCKING: TRAUMA: QUANTITY 4;201.928: QUANTITY 1;201.932: QUANTITY 1;207.742: QUANTITY 1;207.648: QUANTITY 1;04.005.550: QUANTITY 1;04.118.538S: QUANTITY 1;04.211.020S: QUANTITY 1;04.211.018S: QUANTITY 2;412.112S: QUANTITY 1;207.740: QUANTITY 1;04.503.104.01S: QUANTITY 1;04.503.414.01S: QUANTITY 1. ADDITIONAL REPORTED SCREW LOT NUMBERS: 1L44433; 1L93538; 2L12399; 2L22726; 2L63058; 2L64759; 3L51341; 3L65888; 4L11096; 4L36390; H519968; L017742; L493820; L954463; L971682; 2201980; 3L22834, 3L22795, L993946; H622363; H699984; L312722. ADDITIONAL REPORTED SCREW UDI NUMBERS: (B)(4). DEVICE CODE: (B)(4). METHOD CODE: 10 ¿ ACTUAL DEVICE EVALUATED ¿ TOTAL OF 12. 4114 ¿ DEVICE NOT RETURNED ¿ TOTAL OF 18. RESULT CODES: 3221 ¿ NO FINDINGS AVAILABLE ¿ TOTAL OF 18. 3243 ¿ STRESS PROBLEMS IDENTIFIED ¿ TOTAL OF 5. 3252 ¿ FRACTURE PROBLEM ¿ TOTAL OF 5. 213 ¿ NO DEVICES PROBLEM FOUND ¿ TOTAL OF 1. 3211 ¿ DEFORMATION PROBLEM ¿ TOTAL OF 1. CONCLUSION CODES: 67 ¿ NO PROBLEM DETECTED ¿ TOTAL OF 19. 4307 ¿ CAUSE TRACED COMPONENT FAILURE ¿ TOTAL OF 9. 19 ¿ CAUSE TRACED TO USER ¿ TOTAL OF 1. 18 - FAILURE TO FOLLOW INSTRUCTIONS ¿ TOTAL OF 1. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
THIS REPORT SUMMARIZES <NOE> 48 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 50 ACTUAL DEVICES FOR BROKEN SCREWS. TWO EVENTS OCCURRED PREOPERATIVELY, FORTY-THREE EVENTS OCCURRED INTRAOPERATIVELY, AND THREE EVENTS OCCURRED POSTOPERATIVELY BY USE OF A HEALTHCARE PROFESSIONAL. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 15-78 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 50 TO 120 KILOGRAMS. GENDER ¿ 10 FEMALE, 10 MALE, AND 28 UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 634280 | UNK - SCREWS: TRAUMA | SCREW, FIXATION, BONE | HWC | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | L017742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |