BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 24769869 · Received April 2, 2026

    Report

    Report Number
    1220246-2026-01826
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 12, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 12-MAR-2026, A FACILITY REPRESENTATIVE REPORTED VIA SEM-(B)(6) THAT AN AR-8737-38 T10 HEXALOBE SHAFT BROKE DURING A HARDWARE REMOVAL. NO PATIENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457461 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 1392109 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1