BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, SELF RETAINING, AO

    MDR report key: 20470868 · Received October 17, 2024

    Report

    Report Number
    1220246-2024-08182
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 19, 2024
    Report Date
    January 24, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385566
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE DRIVE GEOMETRY AT THE DISTAL TIP OF THE DRIVER SHAFT, T6, AO HAD TWISTED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER ERROR DUE TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD. PER DFU-0023-12 REV 0 CAUTIONS- TO AVOID DAMAGING THE INSTRUMENTS, DO NOT IMPACT OR SUBJECT TO BLUNT FORCE ANY INSTRUMENTS THAT ARE DESIGNED TO BE TURNED OR SCREWED IN. WHEN TWO DEVICES ARE INTENDED TO BE THREADED TOGETHER, ENSURE THAT THEY ARE FULLY ENGAGED PRIOR TO USE.

    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 09/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT TIP BROKE OFF INSIDE THE PATIENT WHILE INSERTING THE SCREW, AND AN AR-18800-03 DRIVER SHAFT WAS WARPED. THE CASE WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050487 DRIVER SHAFT, T6, SELF RETAINING, AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING, AO 1392347 00888867385566

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown