BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 16785435 · Received April 21, 2023

    Report

    Report Number
    1220246-2023-06573
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 21, 2023
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    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 DRIVER SHAFTS TIP BROKE. THIS OCCURRED DURING A CASE THE TIP OF THE DRIVER SNAPPED OFF ON THE FIRST TURN OF THE SCREW REMOVAL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965473 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 1392107 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown