LOCKING DRILL GUIDE WITH TISSUE PROTECTION SLEEVE
Report
- Report Number
- 2939274-2018-50566
- Event Type
- Malfunction
- Date Received
- February 8, 2018
- Report Date
- January 17, 2018
- Manufacturer
- WRIGHTS LANE: SYNTHES USA PRODUCTS LLC
- Product Code
- FZX
- UDI-DI
- 10705034769158
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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. ADDITIONAL NARRATIVE: DEVICE HISTORY RECORD (DHR) REVIEW: PART # 324.061; SYNTHES LOT # 4220573; SUPPLIER LOT # NA; RELEASE TO WAREHOUSE DATE: 08MAR2001; MANUFACTURED BY SYNTHES BRANDYWINE; NO NONCONFORMANCE RECORDS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE INSTRUMENT WAS BROKEN IN TWO PIECES. THE REPAIR TECHNICIAN REPORTED THE SCREW WAS MISSING AND THE SCREW HOLE WAS DAMAGED. MISSING PARTS IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. THE FOLLOWING INVESTIGATION FLOW WAS PERFORMED: VISUAL (APPEARANCE NOT AS EXPECTED). VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF A MISSING SCREW COMPONENT AND DAMAGED HOLE. THE RETURNED DEVICE WAS RETURNED IN TWO PIECES, BUT HAS FALLEN APART DUE TO A MISSING SCREW. THERE IS NO EVIDENCE OF ANY BREAKAGE ON THE DEVICE. THIS DOES NOT AGREE WITH REPORTED CONDITION OF DEVICE BREAKAGE. THE SCREW COMPONENT THAT HOLDS THE FORGED HANDLES TOGETHER IS MISSING AND WAS NOT RETURNED. THE HOLE THAT IS MISSING THE SCREW DOES SHOW POST MANUFACTURING DAMAGE. THE RETURNED DEVICE WAS MANUFACTURED IN MARCH 2001 AND IS OVER 17 YEARS OLD. NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DRILL GUIDE ASSEMBLY DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. A DIMENSIONAL INSPECTION OF FEATURES RELEVANT TO THIS COMPLAINT COULD NOT BE OBTAINED AT CQ BECAUSE THE SCREW WAS NOT RETURNED AND THE HOLE IS DAMAGED. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. THE MOST LIKELY CAUSE FOR THE COMPLAINT CONDITION IS ROUGH HANDLING AND CUMULATIVE WEAR FOR OVER 17 YEARS OF USE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. DATE OF REPORT /DATE REC¿D BY MFR : INITIALLY REPORTED AS JANUARY 18, 2018, BUT SHOULD HAVE BEEN JANUARY 17, 2018. 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.
NO PATIENT INVOLVEMENT. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THIS REPORT IS FOR A DRILL GUIDE - UNKNOWN LOT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART HAS NOT BEEN RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.
FOLLOW-UP 1.
(B)(6) REPORTED THAT AN INSTRUMENT WAS FOUND BROKEN IN 2 PIECES IN THE STERILE PROCESSING DEPT. IT IS NOT KNOWN WHEN AND HOW IT HAPPENED. THERE IS NO REPORTED PATIENT INVOLVEMENT.. THERE IS ONE DEVICE ON THIS COMPLAINT.
(B)(6) REPORTED THAT AN INSTRUMENT WAS FOUND BROKEN INTO TWO (2) PIECES IN THE STERILE PROCESSING DEPARTMENT. IT IS NOT KNOWN WHEN AND HOW IT HAPPENED. THERE IS NO REPORTED PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A DRILL GUIDE. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96562 | LOCKING DRILL GUIDE WITH TISSUE PROTECTION SLEEVE | GUIDE | FZX | WRIGHTS LANE: SYNTHES USA PRODUCTS LLC | 4220573 | 10705034769158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |