DRIVING CAP/THREADED
Report
- Report Number
- 8030965-2020-09473
- Event Type
- Malfunction
- Date Received
- December 7, 2020
- Date of Event
- November 10, 2020
- Report Date
- November 10, 2020
- Manufacturer
- SYNTHES GMBH
- Product Code
- LXH
- UDI-DI
- 07611819499188
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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. 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: D4: LOT D9 G1: MANUFACTURING SITE NAME AND ADDRESS H3, H4, H6: PART NUMBER: 03.010.523 LOT NUMBER: 8853970 MANUFACTURING SITE: BETTLACH RELEASE TO WAREHOUSE DATE: JULY 7, 2014 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE THREADED PART OF THE DRIVING CAP IS BROKEN. THE BROKEN PART IS MISSING. THE DRIVING CAP IS IN A VERY USED CONDITION WITH NUMEROUS HAMMER MARKS ON TOP OF THE HEAD AS WELL AS AT THE BOTTOM SIDE OF THE MECHANICAL STOP, BELOW THE HEXAGON. THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION AS SUCH THE COMPLAINT CONDITION CAN BE CONFIRMED. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. DIMENSIONAL INSPECTION: DUE TO THE MISSING PART AND THE CONDITION OF THE RETURNED DEVICE, A DIMENSIONAL TEST IS NOT APPROPRIATE, AS ALL COMPLAINT-RELEVANT DIMENSIONS CANNOT BE MEASURED AND CAN NO LONGER CORRESPOND TO THE VALID TECHNICAL DRAWINGS SPECIFICATIONS DUE TO THE DAMAGE INCURRED. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH 1.4542 STAINLESS STEEL THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION OF 423 - 468 HV10. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE DISTAL TIP IS BROKEN. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING USE (OFF-AXIS OR EXCESSIVE HAMMER BLOWS BASED ON THE NUMEROUS DENTS ON THE PROXIMAL SURFACE). THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.
COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN INTRAMEDULLARY NAILING OF FEMUR SURGERY ON (B)(6) 2020, THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) IMPACTOR BROKE WHILE ATTACHED TO TFNA INSERTION HANDLE DURING NAIL INSERTION. BROKEN DEVICE WAS REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: INSERT-HANDLE HYBRID (PART# 03.037.011, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1424093 | DRIVING CAP/THREADED | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | SYNTHES GMBH | 8853970 | 07611819499188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSERT-HANDLE HYBRID |