BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T10, NON-RETAINING

    MDR report key: 25159650 · Received May 13, 2026

    Report

    Report Number
    1220246-2026-02829
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385603
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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.

    Description of Event or Problem · 0

    ON 22-APR-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-18800-25 NON-RETAINING T10 DRIVER SHAFT WAS BROKEN. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535457 DRIVER SHAFT, T10, NON-RETAINING ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T10, NON-RETAINING 00888867385603

    Patients

    Seq Age Sex Outcome Treatment
    1