BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORX 8 DRIVER, NIPPLE TIP

    MDR report key: 22142150 · Received June 4, 2025

    Report

    Report Number
    2031009-2025-00012
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 7, 2025
    Report Date
    June 4, 2025
    Manufacturer
    TRIMED, INC.
    Product Code
    HXX
    UDI-DI
    00842188126048
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A SALES REP REPORTED ON (B)(6) 2025 THAT WHEN A SURGEON WAS TIGHTENING THE 2ND MOST RADIAL 2.4 TPEG INTO THE VOLAR FIXED ANGLE PLATE THE TIP OF THE DVTX-8 NP BROKE FLUSH WITH THE SCREW HEAD. IT WAS REPORTED THAT THE BROKEN PIECE OF THE DRIVER TIP WAS UNABLE TO BE REMOVED FROM THE SCREW. NO CURRENT PATIENT IMPACT REPORTED OR TIME DELAY REPORTED BY THE SURGEON. POTENTIAL FOR PATIENT IMPACT IF PROSTHESIS REMOVAL IS REQUIRED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627137 TORX 8 DRIVER, NIPPLE TIP TORX 8 DRIVER, NIPPLE TIP HXX TRIMED, INC. DVTX-8 NP 00842188126048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown