BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, SELF RETAINING, AO

    MDR report key: 21848196 · Received April 16, 2025

    Report

    Report Number
    1220246-2025-01465
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 27, 2025
    Report Date
    August 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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: G3, H3, H6. ONE UNPACKAGED AR-18800-03 T6, AO DRIVER SHAFT BATCH NUMBER: 1392240 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THE LASER MARKINGS WERE FADED AND THE DRIVER TIP WAS TWISTED/BENT. 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-TORQUING/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD. REFER TO INVESTIGATION PHOTOS. COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 03/27/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT AND AN AR-18800-04 DRIVER SHAFT ARE OVER TORQUED AND TWISTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133507 DRIVER SHAFT, T6, SELF RETAINING, AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING, AO 1392240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown