BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, SELF RETAINING, AO

    MDR report key: 21313264 · Received February 5, 2025

    Report

    Report Number
    1220246-2025-00199
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 7, 2025
    Report Date
    March 19, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385566
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-18800-03 DRIVER SHAFT BATCH NUMBER: 1392347 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT THE DRIVE GEOMETRY AT THE DISTAL TIP OF THE DEVICE WAS TWISTED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO OVER-TORQUEING/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD.

    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 01/09/2025 A SALES REPRESENTATIVE REPORTED, VIA (B)(4), THAT AN AR-18800-03 DRIVER SHAFT, T6, SELF-RETAINING, WAS NO LONGER VIABLE FOR INSERTING THE IMPLANT AND WAS TORQUED. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 1/13/2025: THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025. AN ADDITIONAL DRIVER IN THE SET WAS USED TO COMPLETE THE CASE. THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53132 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