BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING POLYAXIAL SCREWDRIVER (STAINLESS STEEL)

    MDR report key: 5150037 · Received October 14, 2015

    Report

    Report Number
    2027467-2015-00188
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 18, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE FAILED AREA UNDER MICROSCOPE REVEALS CIRCULAR FRACTURE LINES INDICATIVE OF A TORSIONAL OVERLOAD. MECHANICAL TESTING ON THE WORST CASE T25 HEXALOBE DRIVER SHAFT WAS PERFORMED TO ENSURE THE HEXALOBE DESIGN WAS SUFFICIENT TO ACCOMMODATE ANTICIPATED LOADING CONDITIONS. THE RESULTS PRESENTED IN TR-100375 SHOW THAT THE AVERAGE APPLIED TORQUE RESULTING IN HEXALOBE TIP BREAKAGE IS 137.69IN-LBS, WHICH IS APPROXIMATELY 1.3X GREATER THAN THE AVERAGE TORQUE REQUIRED TO BREAK THE ZODIAC DRIVER HEX TIP PART NUMBER 62941 (105.63IN-LBS REPORTED IN TR-100389). IN THE PAST FIVE YEARS, THERE HAVE BEEN NO COMPLAINTS FOR BROKEN HEX TIPS ON ZODIAC DRIVER PART NUMBER 62941; THEREFORE, THE IMPROVED STRENGTH OF THE ARSENAL DRIVERS OVER THE ZODIAC DRIVERS SHOULD BE SUFFICIENT UNDER TYPICAL LOADING CONDITIONS. THE REPORTED FAILURE MAY BE A RESULT OF IMPLANTATION IN EXTREMELY DENSE BONE OR INSUFFICIENT BONE PREPARATION PRIOR TO INSERTION OF THE IMPLANT WHICH LED TO INCREASED TORSIONAL LOADING ON THE DRIVER.

    Additional Manufacturer Narrative · 1

    THE ARSENAL CURVED PROBE IS CURRENTLY BEING EVALUATED. A FOLLOW UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THE SURGEON WAS INSERTING AN ILIAC SCREW ON THE RIGHT SIDE OF THE PATIENT. AS HE WAS USING THE ARSENAL T-HANDLE TO FINISH, ON THE VERY LAST TURN THE TIP OF THE SCREWDRIVER BROKE AND DETACHED FROM THE INSTRUMENT. THE DETACHED SECTION REMAINS POSITIONED WITHIN THE SCREW IMPLANTED IN THE PATIENT'S ILIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680213 LOCKING POLYAXIAL SCREWDRIVER (STAINLESS STEEL) HXX HXX ALPHATEC SPINE INC 87011 7405101

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other