BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 24701924 · Received March 26, 2026

    Report

    Report Number
    8030965-2026-02874
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    January 23, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    07612334171092
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: H3, H6: PRODUCT CODE: 03.043.028. LOT: 21456205. RELEASE TO WAREHOUSE DATE: 27 JANUARY 2022. EXPIRATION DATE: NA. SUPPLIER: BÄCHLER FEINTECH AG. MANUFACTURING SITE: WERK SELZACH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE WELD OF THE PIN WAS BROKEN AND SCRATCHES AROUND THE PIN AREA WERE OBSERVED. IN ADDITION, THE INTERNAL CONNECTING ROD (PART: 60224630) WAS BROKEN AT ONE SIDE, THE FRAGMENT COULD REMAIN INSIDE THE DEVICE, HOWEVER, THIS CANNOT BE CONFIRMED, DUE TO INACCESSIBILITY OF SEEING INSIDE. A FUNCTIONAL TEST WAS PERFORMED, AND THE PIN WAS OBSERVED TO MOVE, INDICATING THAT IT BACKED OUT FROM ITS POSITION. SCRATCHES: THIS TYPE OF DAMAGE IS CONSISTENT WITH OTHER TOOLS AND HARD EDGES COMING IN CONTACT WITH THE DEVICE, PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. NOTE: A DRIVING CAP FROM FAMILY 03.043.028 WAS EVALUATED AND INVESTIGATED BY R&D. THE OBSERVED CONDITION OF THE PIN HAS BEEN PREVIOUSLY ASSESSED BY MATERIALS AND TESTING. MATERIALS AND TESTING PROVIDED DRAFTED REPORT THAT SHOWED SOME DEFICIENCIES IN THE WELD. CONCLUSION FROM R&D WAS THAT ALTHOUGH THE WELD MIGHT NOT BE PERFECT THERE MUST BE SOME SIGNIFICANT LOAD LEADING TO THE FAILURE OF THE WELD. MATERIALS AND TESTING SUBSEQUENTLY PERFORMED A FINITE ELEMENT ANALYSIS TO INVESTIGATE ORIGIN OF STRESS AT THE INTERFACE BETWEEN CROSS PIN AND PULL BUTTON. ANALYSIS SHOWED THAT STRONG OFF AXIS HAMMER BLOWS CAN LEAD TO OSCILLATIONS IN THE SYSTEM THAT CAN CAUSE STRESS THAT CAN LEAD TO BREAKAGE OF THE LASER WELD AT THE END OF THE PIN AND SUBSEQUENT MIGRATION. SURGICAL TECHNIQUE GUIDE MENTIONS AT PAGE 16: TO USE THE HAMMER, ATTACH THE DRIVING CAP TO THE INSERTION HANDLE AND SECURE IT BY TWISTING IT ONE QUARTER TURN. APPLY LIGHT AND CONTROLLED HAMMER BLOWS TO SEAT THE NAIL. NOTES: THE HAMMER GUIDE MAY AID IN CONTROLLING THE DIRECTION OF THE HAMMER BLOWS. THEREFORE, THE HAMMER GUIDE CAN BE ATTACHED TO THE BACK END OF THE DRIVE CAP BY SCREWING BOTH PARTS TOGETHER. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DRIVING CAP 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 DEPUY SYNTHES 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. THE FOLLOWING DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: - DRIVING CAP DWG. - CONNECTING ROD DRIVING CAP. - TN-ADVANCED TIBIAL NAILING SYSTEM INFRAPATELLAR APPROACH SURGICAL TECHNIQUE GUIDE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A TRAUMA PROCEDURE ON (B)(6) 2026. THE PIN IN THE TIBIAL NAIL IMPACTOR HAD BACKED OUT AND THE IMPACTOR NEEDS TO BE REPLACED. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765078 DRIVING CAP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 21456205 07612334171092

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male