BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE CUTTER, 1.1MM

    MDR report key: 22438775 · Received July 8, 2025

    Report

    Report Number
    2031009-2025-00018
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 8, 2025
    Manufacturer
    TRIMED, INC.
    Product Code
    HXZ
    UDI-DI
    00842188113697
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A SALES REP REPORTED ON 10JUN2025 THAT CUTRWIR-1.1 FROM THE TRIMED WRIST FIXATION SYSTEM BROKE DURING SURGERY. SURGEON REPORTED THIS ISSUE CAUSED A 40 MINUTE DELAY UNTIL THEY FOUND A REPLACEMENT. GIVEN THIS SYSTEM IS USED ONLY ONCE A MONTH, THIS ISSUE WAS NOT DUE TO HEAVY USAGE. IT WAS CONFIRMED THAT THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT AND NO BROKEN PARTS OF THE DEVICE WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857164 WIRE CUTTER, 1.1MM WIRE CUTTER, 1.1MM HXZ TRIMED, INC. CUTRWIR-1.1 00842188113697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other