BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORX 8 DRIVER, 110MM NIPPLE TIP

    MDR report key: 22959377 · Received September 3, 2025

    Report

    Report Number
    2031009-2025-00024
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 3, 2025
    Manufacturer
    TRIMED INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SALES REP REPORTED ON (B)(6) 2025 THAT THEY HAD A DVTX-8/110 AO NP BREAK AT THE TIP WHILE INSERTING A 2.4 THREADED LOCKING PEG INTO A VOLAR BEARING PLATE DURING A CASE. IT WAS REPORTED THAT THEY WERE UNABLE TO REMOVE THE BROKEN DRIVER PIECE FROM THE PEG, SO IT WAS LEFT IN. SHOULD NOT CAUSE ANY ISSUES SINCE IT WAS FLUSH WITH THE HEAD OF THE SCREW. THERE WAS NO DELAY IN THE CASE. NO PICTURES OR X-RAYS WERE PROVIDED BUT THE REMAINDER OF THE DRIVER IS AVAILABLE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335523 TORX 8 DRIVER, 110MM NIPPLE TIP TORX 8 DRIVER, 110MM NIPPLE TIP HXX TRIMED INC DVTX-8/110 AO NP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown