DRIVING CAP/THREADED
Report
- Report Number
- 8030965-2025-03404
- Event Type
- Malfunction
- Date Received
- April 8, 2025
- Date of Event
- March 16, 2025
- Manufacturer
- SYNTHES GMBH
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). 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. H3, H6: PRODUCT CODE: 03.010.523, LOT NUMBER: L812335: RELEASE TO WAREHOUSE DATE: APRIL 26, 2018. MANUFACTURING SITE: SYNTHES GMBH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: THE PHOTO INVESTIGATION REVEALED THAT DRIVING CAP/THREADED HAS BROKEN. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCE. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE DRIVING CAP/THREADED HAS BROKEN BECAUSE OF CAUSE TRACED TO COMPONENT FAILURE AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.
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. H11 ADDITIONAL NARRATIVE: ADDED: D10 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: H3, H6: PRODUCT CODE: 03.033.001, LOT NUMBER: L862514: RELEASE TO WAREHOUSE DATE: JULY 13, 2018. MANUFACTURING SITE: SYNTHES GMBH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: THE PHOTOGRAPHS PROVIDED WERE REVIEWED, HOWEVER THE PROVIDED EVIDENCE WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT OF INABILITY TO ASSEMBLE/DISASSEMBLE. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE PHOTOGRAPHS PROVIDED ARE NOT REPRESENTATIVE OF THE REPORTED COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPAEDIC QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.
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. H11 ADDITIONAL NARRATIVE: H6: THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS , HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT [03.010.523, DRIVING CAP/THREADED] HAS BROKEN . THE OBSERVED CONDITION OF THE DEVICE WAS CONSIST WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCE. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE [DRIVING CAP/THREADED] WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE DRIVING CAP/THREADED HAS BROKEN BECAUSE OF CAUSE TRACED TO COMPONENT FAILURE AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF MEDTECH ORTHOPEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PRODUCT CODE: 03.010.523. LOT NUMBER : L812335 RELEASE TO WAREHOUSE DATE : 26.APR.2018. MANUFACTURING SITE: SYNTHES GMBH . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. ADDED: D10 (CONCOMITANT). CORRECTED: G1 (MANUFACTURING SITE NAME), H4. H3, H4, H6: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE DISTAL TIP WAS BROKEN. THE BROKEN FRAGMENT REMAINS INSIDE THE MATING DEVICE. NO OTHER ISSUES WERE IDENTIFIED. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO UNINTENDED FORCES. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. PER THE FRN-ADVANCED FEMORAL RECON NAILING SYSTEM (FRNA) SURGICAL TECHNIQUE THE FOLLOWING RELEVANT STATEMENT WAS FOUND: TO USE A HAMMER, SCREW THE DRIVING CAP INTO THE INSERTION HANDLE AND TIGHTEN WITH THE RATCHET WRENCH. WHILE APPLYING LIGHT BLOWS, MONITOR THE TIP OF THE NAIL USING IMAGE INTENSIFICATION. VERIFY THAT THERE IS NO EVIDENCE OF IMPINGEMENT DISTALLY. REMOVE THE DRIVING CAP ONCE THE NAIL HAS BEEN SEATED. PRECAUTIONS: DO NOT STRIKE THE INSERTION HANDLE DIRECTLY. A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DRIVING CAP/THREADED WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW (DHR): PART# 03.010.523. LOT # L812335. MANUFACTURING SITE: WERK BETTLACH. MANUFACTURING DATE: 26 JUNE 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. H11 ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT THE THREADED PORTION OF THE IMPACTOR BROKE OFF WHILE TRYING TO DRIVE THE NAIL; IT IS STUCK INSIDE THE NAIL JIG SO IT CAN NO LONGER BE USED. THE NAIL WAS IMPLANTED WITH NO ISSUES OR ADDITIONAL MEDICAL INTERVENTION REQUIRED. NO FRAGMENTS WERE LEFT IN THE PATIENT. SURGICAL DELAY UNKNOWN. NO PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739864 | DRIVING CAP/THREADED | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | SYNTHES GMBH | L812335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Male | RADIOLUCENT INSERTION HANDLE FRN| UNK - NAILS |