BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH MINI QUICK COUPLING

    MDR report key: 21047920 · Received December 31, 2024

    Report

    Report Number
    8030965-2024-15422
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWX
    UDI-DI
    10886982187192
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    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. INVESTIGATION SUMMARY: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED "IT WAS REPORTED THAT METRO TRAY CAME BACK FROM THE CASE WITH THE SCREWDRIVER SHAFT WEDGED INTO THE HANDLE. IT IS NOT POSSIBLE TO REMOVE. THERE WAS NO PATIENT CONSEQUENCES REPORTED." THE REPAIR TECHNICIAN REPORTED THAT THE DEVICE FAILED COSMETICS TEST, ARRIVED WITHOUT ATTACHMENT WEDGED IN QUICK COUPLING, DAMAGED OPENING FOR ATTACHMENT. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS FAULTY PARTS. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS NOT CONFIRMED. DEVICE HISTORY LOT: PART # 311.01.98. SYNTHES LOT # 181702. SUPPLIER LOT # 181702. RELEASE TO WAREHOUSE DATE: 16 DEC 2021. SUPPLIER: (B)(4). NO NCR'S GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW: 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. 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 AN UNKNOWN DATE, THE METRO TRAY CAME BACK FROM THE CASE WITH THE SCREWDRIVER SHAFT WEDGED INTO THE HANDLE. IT IS NOT POSSIBLE TO REMOVE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782440 HANDLE WITH MINI QUICK COUPLING BONE TAP HWX SYNTHES GMBH 181702 10886982187192

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown