BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP

    MDR report key: 21435024 · Received February 21, 2025

    Report

    Report Number
    8030965-2025-01811
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 3, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. H11 ADDITIONAL NARRATIVE: H3, H6: PART:03.043.028. LOT: 21639401. MANUFACTURING SITE: WERK SELZACH. SUPPLIER: BÄCHLER FEINTECH AG. RELEASE TO WAREHOUSE DATE: 23 AUG 2021. EXPIRATION DATE:NA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE WELD OF THE PIN WAS BROKEN. PIN WAS NOT RETURNED FOR ANALYSIS. A COMPLETE FUNCTIONAL TEST CAN NOT BE PERFORMED DUE TO BREAKAGE AND MISSING PIN, HOWEVER, DUE TO THIS CONDITION THE SPRING AND PULL BUTTON WERE UNATTACHED CONFIRMING THE COMPLIANT CONDITION. 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 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON JANUARY 3, 2025 THE DRIVING CAP HAD THE PIN THAT IS WELDED FALL OUT, MAKING THE CAP/SPRING FALL APART. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692956 DRIVING CAP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 21639401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown