BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORX 8 DRIVER, NIPPLE TIP

    MDR report key: 22438755 · Received July 8, 2025

    Report

    Report Number
    2031009-2025-00017
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 8, 2025
    Manufacturer
    TRIMED, INC.
    Product Code
    HXX
    UDI-DI
    00842188126048
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SALES REP REPORTED ON (B)(6) 2025 THAT A DVTX-8 NP BROKE DURING SURGERY. THE SURGEON STATED THAT DURING THE FINAL TIGHTENING OF THE DISTAL 2.4 MM LOCKING PEGS, THE TIP OF THE SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW. THE TIP OF THE DRIVER HAD COLD WELDED INTO THE SCREW AND THE SURGEON COULD NOT REMOVE IT SO IT REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS PROVIDED ON 08JUL2025 THAT THIS CAUSED A 2-MINUTE DELAY IN SURGERY AND THE SURGEON DOES NOT BELIEVE LEAVING THE BROKEN PIECE IN THE SCREW HEAD WILL CAUSE THE PATIENT ADDITIONAL HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399664 TORX 8 DRIVER, NIPPLE TIP TORX 8 DRIVER, NIPPLE TIP HXX TRIMED, INC. 00842188126048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown