BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T10 HEXALOBE, CANNULATED

    MDR report key: 23304456 · Received October 15, 2025

    Report

    Report Number
    1220246-2025-04630
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 6, 2025
    Report Date
    February 2, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867046115
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-16 DRIVER TWISTED UP WHILE THE HCP WAS PUTTING IN THE SCREWS. A DIFFERENT DRIVER WAS BROUGHT IN TO COMPLETE THE CASE. NO TIME WAS ADDED TO THE CASE, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350648 DRIVER SHAFT, T10 HEXALOBE, CANNULATED ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T10 HEXALOBE, CANNULATED 6791126 00888867046115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown