BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH QUICK COUPLING, SMALL

    MDR report key: 24851834 · Received April 11, 2026

    Report

    Report Number
    8030965-2026-03339
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 25, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWX
    UDI-DI
    07611819019379
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREWDRIVER BROKE AT THE WOODEN PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334306 HANDLE WITH QUICK COUPLING, SMALL BONE TAP HWX SYNTHES GMBH 07611819019379

    Patients

    Seq Age Sex Outcome Treatment
    1