BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T10, NON-RETAINING

    MDR report key: 20382759 · Received October 7, 2024

    Report

    Report Number
    1220246-2024-08013
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 12, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385603
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 IS CONFIRMED. ONE UNPACKED AR-18800-25 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. 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 COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO MISUSE DUE TO USE ERROR OF OVER-TORQUING/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD.

    Description of Event or Problem · 0

    ON 09/12/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-18800-25 DRIVER SHAFT WARPED DURING A CASE. THE CASE WAS COMPLETED USING A BACKUP DRIVER IN THE TRAY, AND THERE WAS NO DELAY. THIS WAS DISCOVERED DURING A FOOT AND ANKLE RECONSTRUCTION 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
    216602 DRIVER SHAFT, T10, NON-RETAINING ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T10, NON-RETAINING 1392247 00888867385603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown