BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 24269298 · Received February 5, 2026

    Report

    Report Number
    1220246-2026-00432
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 15, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 15-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-8737-38 T10 HEXALOBE TIPS OF DRIVER SHAFTS BROKE OFF WHEN INSERTING THE SCREW. BOTH PIECES WERE REMOVED. THIS WAS DISCOVERED DURING A TTO CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547192 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 392304 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1