BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T10 HEXALOBE, CMP FT

    MDR report key: 9327790 · Received November 15, 2019

    Report

    Report Number
    1220246-2019-01415
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    October 9, 2019
    Report Date
    January 27, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867127166
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT WAS CONFIRMED. VISUAL EVALUATION REVEALED THE DRIVER TIP BROKE OFF. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDE CONTINUALLY APPLYING TORQUE AFTER THE SCREW IS FULLY SEATED, TORQUING WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, AND/OR NOT FULLY SEATING THE DRIVER INTO THE SCREW DURING TIGHTENING.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TALONAVICULAR ARTHROSIS SURGERY THE ARTHREX DEVICE AR-8737-38 BROKE INSIDE THE PATIENT. IT WAS NOT POSSIBLE FOR THE SURGEON TO REMOVE THE BROKEN FRAGMENT. EVEN THOUGH THE DEVICE BROKE DURING USE THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO CHANGE THE SURGICAL TECHNIQUE OR PERFORM A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122373 T10 HEXALOBE, CMP FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. T10 HEXALOBE, CMP FT 1391616 00888867127166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other