BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T10, NON-RETAINING

    MDR report key: 19763678 · Received July 17, 2024

    Report

    Report Number
    1220246-2024-06797
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385603
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION HAS NOT BEEN CONFIRMED AS THE REPORTED FAILURE COULD NOT BE REPLICATED. ONE UNPACKED AR-18800-25 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS DELIVERED FOR EVALUATION, INDEPENDENT OF THE AR-8700RH RATCHETING HANDLE. VISUAL INSPECTION FOUND THAT THE HEX TIP OF THE DRIVER WAS TWISTED. IT WAS NOTED THAT THE LASER MARKS ARE FADING MOST LIKELY BECAUSE THE REPROCESSING OF THE DEVICE. FUNCTIONAL TESTING OF BATCH 1392239 FOR THE AR-18800-25 INDICATED THAT THE DRIVER DOES NOT BECOME JAMMED WITHIN THE RATCHETING MECHANISM. NO PROBLEM FOUND.

    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 06/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-25 DRIVER SHAFT AND AR-8700RH RATCHETING HANDLE HAS BEEN COLD WELDED TOGETHER. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351330 DRIVER SHAFT, T10, NON-RETAINING ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T10, NON-RETAINING 1392239 00888867385603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown