BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 16361670 · Received February 13, 2023

    Report

    Report Number
    1220246-2023-06259
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 23, 2023
    Report Date
    March 13, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-8737-38 DRIVER SHAFT, T10 HEX, CANNULATED SERIAL/BATCH NUMBER (B)(6) WERE RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE DEVICE HEX TIP BROKEN OFF. THE FRAGMENTS GENERATED DURING THE EVENT WERE NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS UNDETERMINED. HOWEVER, THE MOST LIKELY PROBABLE CAUSE IS APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION.

    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 SALES REPRESENTATIVE VIA SEMS THAT AN AR-8737-38 T10 HEXALOBE BROKE DURING A CASE. THE SURGEON TRIED TO SCREW A 4.0 HEADLESS SCREW IN IT AND SNAPPED THE HEAD OF THE DRIVER. IT WAS REPLACED AND THE SAME EVENT OCCURRED. THE HEAD ALSO BROKE. ANOTHER T-10 WAS USED FROM ANOTHER SET TO COMPLETE THE CASE. THE SCREWS WERE HARD TO GET OUT BUT ALL WAS RETRIEVED. NO PATIENT AFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797808 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 1392124 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown