BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER SHAFT, T-15, MEDIUM

    MDR report key: 9193537 · Received October 15, 2019

    Report

    Report Number
    1220246-2019-01359
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    September 27, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867225190
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE TIP TWISTED AND BROKE OFF. THE MOST LIKELY CAUSE(S) OF THIS TYPE OF EVENT INCLUDES CONTINUALLY APPLYING TORQUE AFTER THE IMPLANT IS FULLY SEATED, APPLYING TORQUE WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, LEVERAGING, OR TORQUING WHILE LEVERAGING THE DEVICE.

    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 A REVISION SURGERY TOOK PLACE. ACCORDING TO THE SURGEON, THE REVISION WAS NOT NECESSARY DUE TO A PRODUCT DEFECT BUT WAS DUE TO THE WORN-OUT ROTATOR CUFF. THE SURGEON'S STATEMENT IS THAT IT IS NORMAL AND CAN HAPPEN AFTER SEVERAL YEARS AFTER IMPLANTATION OF THE ECLIPSE. WHILE IMPLANTING THE REVERSE PROSTHESIS, THERE WERE DIFFICULTIES IN PLACING THE GLENOID BASEPLATE. THE 30MM PERIPHERAL SCREW TILTED IN THE SNAP RING SO THAT THE SCREW SEIZED UP. IN ADDITION, THE SCREWDRIVER TIP OF AR-9545-T15-02 - BATCH 8001903 BROKE OFF INSIDE THE SCREW. THEREFORE IT WAS NO LONGER POSSIBLE TO REMOVE THE SCREW. THE SURGEON TRIED IT SEVERAL TIMES AND FINALLY MILLED OFF THE SCREW. THE AR-9545-T15-03 - BATCH 8001549 SCREWDRIVER WAS ALSO USED DURING THE SURGERY. THE SCREWDRIVER TIP OF THIS DEVICE IS TWISTED. IT WAS NOT NECESSARY TO CHANGE THE SURGICAL TECHNIQUE. THE SURGERY WAS COMPLETED SUCCESSFULLY. AT THE TIME OF INITIAL REPORT NO FURTHER INFORMATION WAS PROVIDED. UPDATE 15-OCT-2019: THE INITIAL SURGERY DATE IS UNKNOWN. THE CUSTOMER CANNOT PROVIDE US THIS INFORMATION. THE SCREW IS COLD-WELDED WITH THE SNAP RING, WHICH MEANS THE SCREW IS WELL FIXED. THE TORQUE INDICATOR WAS USED BUT IT WAS NOT POSSIBLE TO PLACE THE SCREW PROPER INTO THE TORQUE INDICATOR. A LARGE PART OF THE SCREW HEAD WAS MILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983738 DRIVER SHAFT, T-15, MEDIUM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T-15, MEDIUM 8001903 00888867225190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other