BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 HEXALOBE, ISO, CANN.

    MDR report key: 17615895 · Received August 24, 2023

    Report

    Report Number
    1220246-2023-07625
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    July 27, 2023
    Report Date
    December 13, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263765
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-8750-03 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE DRIVER'S TIP WAS BROKEN OFF. FUNCTIONAL TESTING WAS NOT CONDUCTED DUE TO THE DAMAGE TO THE INSTRUMENT'S TIP. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. DEVICE MANUFACTURING DATED. 29-SEP-2020.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A ARTHREX REPRESENTATIVE VIA SEMS THAT AN AR-8750-03 DRIVER SHAFT, T15 HEXALOBE, BROKE WHILE INSERTING A 5.0 COMPRESSION SCREW AND GOT STUCK INSIDE THE SCREW ITSELF. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171283 T15 HEXALOBE, ISO, CANN. ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T15 HEXALOBE, ISO, CANN. 012039 00888867263765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown