BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH QUICK COUPLING, SMALL

    MDR report key: 25216439 · Received May 19, 2026

    Report

    Report Number
    8030965-2026-04693
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    January 1, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWX
    UDI-DI
    10886982187390
    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

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, QUICK COUPLING SMALL DRIVER HANDLE WAS STICKING/NOT RELEASING WHEN DRIVER ATTACHMENTS ARE INSERTED/REMOVED. IT WAS NOTICED DURING A PROCEDURE WHEN TRYING TO REMOVE AN ATTACHMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208350 HANDLE WITH QUICK COUPLING, SMALL BONE TAP HWX SYNTHES GMBH H886585 10886982187390

    Patients

    Seq Age Sex Outcome Treatment
    1