BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 HEXALOBE, ISO, CANN.

    MDR report key: 20309922 · Received September 26, 2024

    Report

    Report Number
    1220246-2024-07855
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 9, 2024
    Report Date
    June 10, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263765
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 OVERSTRESSING A DEVICE THAT IS DAMAGED NATURALLY AND INEVITABLY AS A RESULT OF NORMAL WEAR OR AGING FROM REPEATED USAGE/REPROCESSING. MANUFACTURED DATE: 19-DEC-2016.

    Description of Event or Problem · 0

    ON 09/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-12 DRIVER SHAFT ENDED UP GETTING A SCREW STUCK ON IT DURING THE REMOVAL, AND WE COULD NOT REMOVE IT FROM THE DRIVER ITSELF, AND (2) AR-8750-03 DRIVER SHAFTS BROKE DURING THE REMOVAL. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235021 T15 HEXALOBE, ISO, CANN. ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T15 HEXALOBE, ISO, CANN. 031650 00888867263765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown