BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, SELF RETAINING,MINI AO

    MDR report key: 23853662 · Received December 19, 2025

    Report

    Report Number
    1220246-2025-05732
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867312692
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS THE VISUAL EVALUATION OF THE RECEIVED AR-18700-15 WITH BATCH 1392438 REVEALED THAT THE END OF THE DEVICE IS BROKEN OFF (SEE EVALUATION PICTURE 4). THE BROKEN-OFF PART IS STUCK IN THE AR-18700-44 WITH BATCH 672405A OF (B)(4). A FUNCTIONAL TEST WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. A MOST LIKELY CAUSE IS TYPICALLY APPLYING EXCESSIVE LEVERAGING FORCES DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE OSTEOSYNTHESIS OF THE HAND, THE DRIVER SHAFT BROKE IN THE HANDLE. NO FRAGMENTS REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251936 DRIVER SHAFT, T6, SELF RETAINING,MINI AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING,MINI AO 1392438 00888867312692

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown