BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, SELF RETAINING, AO

    MDR report key: 23132474 · Received September 24, 2025

    Report

    Report Number
    1220246-2025-04099
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 8, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ONE UNPACKAGED AR-18800-03, DRIVER SHAFT BATCH NUMBER: 1392347 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT 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 09/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07057750 THAT AN AR-18800-03 DRIVER TORQUED DURING USE. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613991 DRIVER SHAFT, T6, SELF RETAINING, AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING, AO 1392347

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown