BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10NM TORQUE WRENCH 11MM ACROSS THE FLATS

    MDR report key: 3003535 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10141
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. LOT NUMBER PROVIDED IS INVALID. IT IS THE SERIAL NUMBER FOR THE PART. (B)(4). VISUAL INSPECTION REVEALED THE 10MM TORQUE WRENCH HAD A DISCOLORED SHAFT. HEX FEATURE HAD DENTS AND APPEARS WORN. ALL MEASURABLE FEATURES AND TORQUE VALUES ARE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LUMBAR FUSION PROCEDURE WHEN THE FINAL TIGHTENING WITH TORQUE WRENCH AND TWO TI COLLARS WITH GROOVES BROKE. ANOTHER TORQUE WRENCH AND COLLARS WERE USED TO COMPLETE THE PROCEDURE. ALL PIECES WERE RETRIEVED. THIS IS REPORT 3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86956 10NM TORQUE WRENCH 11MM ACROSS THE FLATS HXC SYNTHES MONUMENT 0440

    Patients

    Seq Age Sex Outcome Treatment
    1