BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, SELF RETAINING, AO

    MDR report key: 23108897 · Received September 22, 2025

    Report

    Report Number
    1220246-2025-03985
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 2, 2025
    Report Date
    October 20, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-18800-03 BATCH 1392503 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE HEX TIP WAS TWISTED. FUNCTIONAL TESTING CANNOT BE PERFORMED AS THE DEVICE WAS DAMAGED. TO PREVENT OVER-TORQUING, A TORQUE-INDICATING ADAPTER IS RECOMMENDED FOR USE WITH THE DEVICE. THE MOST LIKELY CAUSE IS OVER-TORQUING/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 (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT BECAME WARPED DURING A CASE THE PREVIOUS WEEK. THE DRIVER WARPING HAD NO EFFECT ON THE PATIENT, NO DELAY, OR OTHER ADVERSE EFFECTS. THE DOCTOR SWITCHED TO A NEW DRIVER TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027519 DRIVER SHAFT, T6, SELF RETAINING, AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING, AO 1392503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown