UNK - SCREWS: TRAUMA
Report
- Report Number
- 2939274-2020-00440
- Event Type
- Malfunction
- Date Received
- January 28, 2020
- Report Date
- November 7, 2019
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HWC
- 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. 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. ADDITIONAL REPORTED SCREW LOT NUMBERS: H614042, 9960947. 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.
H10: 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. 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. 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. ADDITIONAL REPORTED SCREW LOT NUMBERS: L589534, 1L28338. 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. 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. 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: L638474, 4L99740, 5L21994, 5L24056. 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 SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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: OF THE 102 DEVICES REPORTED 22 DEVICES WERE RECEIVED FOR EVALUATION. ADDITIONAL REPORTED SCREW PART NUMBERS: 02.200.030: QUANTITY 1; 02.214.113: QUANTITY 1; 02.226.800: QUANTITY 1; 04.130.210S: QUANTITY 1; 04.503.104.01: QUANTITY 2; 04.503.104.20: QUANTITY 2; 04.503.105.01: QUANTITY 5; 04.503.225.01C: QUANTITY 1; 04.511.206.04S: QUANTITY 1; 201.928: QUANTITY 1; 202.824: QUANTITY 1; 207.740: QUANTITY 1; 214.042: QUANTITY 1; 214.740: QUANTITY 1; 214.836: QUANTITY 3; 214.84: QUANTITY 1; 400.834: QUANTITY 9; 400.834S: QUANTITY 4; 400.835: QUANTITY 38; 401.110: QUANTITY 2; 402.214S: QUANTITY 1; 404.840S: QUANTITY 1; 412.110S: QUANTITY 1; 412.111S: QUANTITY 1; 412.112S: QUANTITY 1; 412.121S: QUANTITY 1; 412.123S: QUANTITY 1; 412.124S: QUANTITY 1; UNK - SCREWS: CORTEX: TRAUMA: QUANTITY 3; UNK - SCREWS: LOCKING: TRAUMA: QUANTITY 8; UNK - SCREWS: MATRIXNEURO: QUANTITY 1; UNK - SCREWS: TRAUMA: QUANTITY 5 ADDITIONAL REPORTED SCREW LOT NUMBERS: L009860, 9895750, L467716, L385727, L896160, 2L61883, 5L08296, L638474, 4L99740, 5L21994, 5L24056, H199991, 6L39201 ADDITIONAL REPORTED SCREW UDI NUMBERS: (B)(4). UNKNOWN PART NUMBER, UDI UNAVAILABLE DEVICE CODE: 1069 - BREAK - TOTAL OF 102 METHOD CODE: 10 - ACTUAL DEVICE EVALUATED - TOTAL OF 54 4114 - DEVICE NOT RETURNED - TOTAL OF 43 4112 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY - TOTAL OF 1 RESULT CODES: 3221 - NO FINDINGS AVAILABLE - TOTAL OF 43 3243 - STRESS PROBLEMS IDENTIFIED - TOTAL OF 17 3252 - FRACTURE PROBLEM - TOTAL OF 15 114 - OPERATIONAL PROBLEM IDENTIFIED - TOTAL OF 7 213 - NO DEVICE PROBLEM FOUND - TOTAL OF 6 3211 - DEFORMATION PROBLEM - TOTAL OF 9 706 - ASSEMBLY PROBLEM IDENTIFIED - TOTAL OF 1 CONCLUSION CODES: 67 - NO PROBLEM DETECTED - TOTAL OF 49 4307 - CAUSE TRACED COMPONENT FAILURE - TOTAL OF 39 4315 - CAUSE NOT ESTABLISHED - TOTAL OF 4 19 - CAUSE TRACED TO USER - TOTAL OF 5 25 - CAUSE TRACED TO MANUFACTURING - 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. 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. 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. OF THE 102 DEVICES REPORTED 22 DEVICES WERE RECEIVED FOR EVALUATION. ADDITIONAL REPORTED SCREW PART NUMBERS: 02.200.030: QUANTITY 1; 02.214.113: QUANTITY 1; 02.226.800: QUANTITY 1; 04.130.210S: QUANTITY 1; 04.503.104.01: QUANTITY 2; 04.503.104.20: QUANTITY 2; 04.503.105.01: QUANTITY 5; 04.503.225.01C: QUANTITY 1; 04.511.206.04S: QUANTITY 1; 201.928: QUANTITY 1; 202.824: QUANTITY 1; 207.740: QUANTITY 1; 214.042: QUANTITY 1; 214.740: QUANTITY 1; 214.836: QUANTITY 3; 214.84: QUANTITY 1; 400.834: QUANTITY 9; 400.834S: QUANTITY 4; 400.835: QUANTITY 38; 401.110: QUANTITY 2; 402.214S: QUANTITY 1; 404.840S: QUANTITY 1; 412.110S: QUANTITY 1; 412.111S: QUANTITY 1; 412.112S: QUANTITY 1; 412.121S: QUANTITY 1; 412.123S: QUANTITY 1; 412.124S: QUANTITY 1; UNK - SCREWS: CORTEX: TRAUMA: QUANTITY 3; UNK - SCREWS: LOCKING: TRAUMA: QUANTITY 8; UNK - SCREWS: MATRIXNEURO: QUANTITY 1; UNK - SCREWS: TRAUMA: QUANTITY 5. ADDITIONAL REPORTED SCREW LOT NUMBERS: L009860, 9895750, L467716, L385727, L896160, 2L61883, 5L08296, L638474, 4L99740, 5L21994, 5L24056, H199991, 6L39201. ADDITIONAL REPORTED SCREW UDI NUMBERS: (B)(4). UNKNOWN PART NUMBER, UDI UNAVAILABLE.
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.
THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 9 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 3 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 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 39 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 86 KGS. GENDER ¿ 0 FEMALE, 1 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 49 YEARS OLD, PATIENT¿S WEIGHT RANGE: UNKNOWN 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 58 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 4 </NOE> 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 58 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 0 MALE, AND 4 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 2 </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 64-UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 1 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 POUNDS. 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 84 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 109.7 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, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 4 </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 40-54 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 3 FEMALE, 0 MALE, AND 1 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 5 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 38 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 5 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 8 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 51-UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 1 MALE, AND 3 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 2 </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 UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 0 MALE, AND 2 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 63 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 30 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 1 FEMALE, 0 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 42 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 102 ACTUAL DEVICES FOR BROKEN SCREWS. 5 EVENTS OCCURRED PREOPERATIVELY, 97 EVENTS OCCURRED INTRAOPERATIVELY, AND 0 OCCURRED POSTOPERATIVELY BY USE OF A HEALTHCARE PROFESSIONAL. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 14-84 YEARS OLD PATIENT¿S WEIGHT RANGE ¿ 68 TO 185 KILOGRAMS GENDER ¿ 3 FEMALE, 16 MALE, AND 23 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 58 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN 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 14 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN 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 21 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 185 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 63 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES <NOE> 1 </NOE> 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 55 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 1 MALE, AND 0 UNKNOWN.
THIS REPORT SUMMARIZES 42 MALFUNCTION EVENTS INVOLVING A TOTAL OF 102 ACTUAL DEVICES FOR BROKEN SCREWS. 5 EVENTS OCCURRED PREOPERATIVELY, 97 EVENTS OCCURRED INTRAOPERATIVELY, AND 0 OCCURRED POSTOPERATIVELY BY USE OF A HEALTHCARE PROFESSIONAL. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 14-84 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 68 TO 185 KILOGRAMS. GENDER ¿ 3 FEMALE, 16 MALE, AND 23 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 24 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 68 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.
OF THE 102 DEVICES REPORTED 22 DEVICES WERE RECEIVED FOR EVALUATION. ADDITIONAL REPORTED SCREW PART NUMBERS: 02.200.030: QUANTITY 1; 02.214.113: QUANTITY 1; 02.226.800: QUANTITY 1; 04.130.210S: QUANTITY 1; 04.503.104.01: QUANTITY 2; 04.503.104.20: QUANTITY 2; 04.503.105.01: QUANTITY 5; 04.503.225.01C: QUANTITY 1; 04.511.206.04S: QUANTITY 1; 201.928: QUANTITY 1; 202.824: QUANTITY 1; 207.740: QUANTITY 1; 214.042: QUANTITY 1; 214.740: QUANTITY 1; 214.836: QUANTITY 3; 214.84: QUANTITY 1; 400.834: QUANTITY 9; 400.834S: QUANTITY 4; 400.835: QUANTITY 38; 401.110: QUANTITY 2; 402.214S: QUANTITY 1; 404.840S: QUANTITY 1; 412.110S: QUANTITY 1; 412.111S: QUANTITY 1; 412.112S: QUANTITY 1; 412.121S: QUANTITY 1; 412.123S: QUANTITY 1; 412.124S: QUANTITY 1; UNK - SCREWS: CORTEX: TRAUMA: QUANTITY 3; UNK - SCREWS: LOCKING: TRAUMA: QUANTITY 8; UNK - SCREWS: MATRIXNEURO: QUANTITY 1; UNK - SCREWS: TRAUMA: QUANTITY 5. ADDITIONAL REPORTED SCREW LOT NUMBERS: L009860, 9895750, L467716, L385727, L896160, 2L61883, 5L08296, L638474, 4L99740, 5L21994, 5L24056, H199991, 6L39201. ADDITIONAL REPORTED SCREW UDI NUMBERS: (B)(4); UNKNOWN PART NUMBER, UDI UNAVAILABLE. DEVICE CODE: (B)(4). 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> 42 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 102 ACTUAL DEVICES FOR BROKEN SCREWS. 5 EVENTS OCCURRED PREOPERATIVELY, 97 EVENTS OCCURRED INTRAOPERATIVELY, AND 0 OCCURRED POSTOPERATIVELY BY USE OF A HEALTHCARE PROFESSIONAL. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE 14-84 YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ 68 TO 185 KILOGRAMS. GENDER: 3 FEMALE, 13 MALE, AND 26 UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103261 | UNK - SCREWS: TRAUMA | SCREW, FIXATION, BONE | HWC | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | L920553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |