BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, SELF RETAINING, AO

    MDR report key: 18340621 · Received December 15, 2023

    Report

    Report Number
    1220246-2023-09407
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 17, 2023
    Report Date
    January 22, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385566
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKED AR-18800-03 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION FOUND THAT THE HEX TIP OF THE DRIVER WAS TWISTED. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE DAMAGE TO THE DEVICE. A TORQUE-LIMITING HANDLE OR MODULAR TORQUE-LIMITING ADAPTER IS RECOMMENDED FOR USE WITH THE DEVICE TO PREVENT OVER-TORQUING. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USE ERROR OVER-TORQUING/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD.

    Description of Event or Problem · 0

    ON 11/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06404429 THAT (QTY. 2) OF AN AR-18800-03 DRIVER SHAFT TWISTED DESPITE THE SURGEON'S USE OF THE TORQUE LIMITING ADAPTER PRESENT IN THE SET. THEY WERE TOLD THE DEVICES TWISTED BEFORE THE TORQUE LIMITING ADAPTER ENGAGED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928744 DRIVER SHAFT, T6, SELF RETAINING, AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING, AO 1392240 00888867385566

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown