BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, SELF RETAINING, AO

    MDR report key: 18285750 · Received December 7, 2023

    Report

    Report Number
    1220246-2023-09268
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 10, 2023
    Report Date
    November 20, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385566
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. 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 PERFORMED DUE TO THE DAMAGE TO THE DEVICE. A TORQUE-LIMITING HANDLE OR MODULAR TORQUE-LIMITING ADAPTER RECOMMENDED TO BE USED 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.

    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.

    Description of Event or Problem · 0

    ON 11/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-18800-04 DRIVER SHAFTS AND AN AR-18800-03 DRIVER SHAFT BECAME TWISTED. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759488 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