BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T-15, MEDIUM

    MDR report key: 22737867 · Received August 7, 2025

    Report

    Report Number
    1220246-2025-03309
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 18, 2025
    Report Date
    September 26, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867225190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ONE UNPACKAGED AR-9545-T15-02, BATCH: 8001828, WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE INSTRUMENT'S HEX TIP WAS TWISTED/DAMAGED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, WHICH INVOLVES OVER-TORQUING OR OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE PHYSICAL DAMAGE OF THE DEVICE'S TIP. REFER TO THE INVESTIGATION PHOTOS. COMPLAINT ALLEGATION IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 07/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9545-T15-02 DRIVER SHAFT TIP OF SCREWDRIVER WAS TORQUED AND BROKE AT THE HEAD OF THE SCREW WHILE TRYING TO REMOVE THE CENTRAL SCREW FROM THE CUG BASEPLATE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531682 DRIVER SHAFT, T-15, MEDIUM ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T-15, MEDIUM 8001828 00888867225190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown