BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 16808539 · Received April 25, 2023

    Report

    Report Number
    1220246-2023-06579
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 25, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-8737-38 DRIVER SHAFT, T10 HEX, SERIAL/BATCH NUMBER (B)(6), WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE DEVICE¿S HEX TIP HAD BROKEN OFF AND WAS BENT. NO FUNCTIONAL TESTING WAS PERFORMED FOR THIS DEVICE DUE TO THE BROKEN TIP. THE ROOT CAUSE OF THE REPORTED FAILURE MODE IS UNDETERMINED. HOWEVER, THE MOST LIKELY PROBABLE CAUSE IS APPLYING EXCESSIVE MECHANICAL FORCES UPON INSERTION.

    Description of Event or Problem · 0

    ON 03/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-8737-38 DRIVER SHAFTS BROKE. THIS OCCURRED DURING A TTO CASE ON (B)(6) 2023, THE CASE WAS COMPLETED USING A DEVICE FROM A DIFFERENT MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540602 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 1392116 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown