BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORX 8 DRIVER, 110MM NIPPLE TIP

    MDR report key: 20845878 · Received December 4, 2024

    Report

    Report Number
    2031009-2024-00008
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 5, 2024
    Report Date
    December 4, 2024
    Manufacturer
    TRIMED, INC.
    Product Code
    HXX
    UDI-DI
    00842188126055
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SALES REP REPORTED ON 04NOV2024 TO TRIMED, INC. THAT WHEN THE SURGEON IN (B)(6) WAS TIGHTENING THE 2.4MM TPEGS INTO THE DISTAL MOST ULNA HOLE OF THE VOLAR PLATE ON (B)(6) 2024, THE TIP OF THE DVTX-8/110 AO NP SCREWDRIVER SNAPPED FLUSH IN THE HEAD OF THE SCREW. IT WAS REPORTED THAT THE DEVICE WAS NOT BEING USED UNDER POWER, THE BROKEN TIP WAS NOT ABLE TO BE REMOVED AND THE SURGEON REPORTED THE SCREW WAS ADEQUATELY LOCKED AND OPTED TO LEAVE IMPLANT WITH SCREWDRIVER TIP INSITU. THE SURGEON REPORTED NO TIME DELAY, HOWEVER, BELIEVED THERE IS POTENTIAL PATIENT IMPACT IF THE MOST ULNAR SCREW WITH BROKEN SCREWDRIVER TIP REQUIRES REVISION. NO PICTURES OR X-RAYS WERE PROVIDED BUT THE REMAINDER OF THE DEVICE IS AVAILABLE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941458 TORX 8 DRIVER, 110MM NIPPLE TIP TORX 8 DRIVER, 110MM NIPPLE TIP HXX TRIMED, INC. DVTX-8/110 AO NP QM23001 00842188126055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown