BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T-15, SHORT

    MDR report key: 21632448 · Received March 18, 2025

    Report

    Report Number
    1220246-2025-00997
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 27, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867225183
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-9545-T15-01 BATCH 8001845 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION IDENTIFIED DAMAGE TO THE HEX GEOMETRY. THE DRIVER'S TIP HAD NICKS AND WAS TWISTED. THE LASER MARKS ARE FADED AND CORRODED. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE DEVICE'S DAMAGE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR FROM REPETITIVE USAGE. THE DEVICE WAS MANUFACTURED ON 27 NOVEMBER 2018.

    Description of Event or Problem · 0

    ON 03/03/2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT A (QTY. (B)(4)) OF AN AR-9545-T15-01 DRIVER SHAFT AND AN AR-9545-T15-03 DRIVER SHAFT WAS TWISTED AND BENT OVER TIME AND UNABLE TO BE USED AS INTENDED. THE CASE WAS COMPLETED WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372356 DRIVER SHAFT, T-15, SHORT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T-15, SHORT 8001845 00888867225183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown