BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10NM TORQUE WRENCH 11MM ACROSS THE FLATS

    MDR report key: 3051875 · Received April 11, 2013

    Report

    Report Number
    1719045-2013-10572
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    October 25, 2011
    Report Date
    October 25, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    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. EVENT DESCRIPTION UPDATED. NO DHR COULD BE RETRIEVED WITH THE LISTED LOT NUMBER AND PART NUMBER, SO THIS DHR REVIEW COULD NOT BE COMPLETED. ORIGINAL AWARENESS DATE IS (B)(6) 2011. DEVICE MANUFACTURE DATE UNKNOWN, INVALID LOT NUMBER. PLACEHOLDER.

    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. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND THE PART HAD AN OVERALL WORN APPEARANCE. THERE WERE TINY NICKS ALL OVER THE BLACK HANDLE. THE SURFACE FINISH OF THE SHAFT WAS DULL. BOTH CONDITIONS WERE CONSISTENT WITH FIELD USE. ALL DIMENSIONAL AND TORQUE REQUIREMENTS WERE FOUND TO BE IN SPECIFICATION, THEREFORE THIS COMPLAINT IS INVALID.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UNIVERSAL SPINE SYSTEM L3-L5 PROCEDURE FOR A L4 FRACTURE, THE SURGEON WAS TORQUEING THE NUT AND COLLAR DOWN TO THE SCREW AND THE COLLAR CRACKED. ON THE NUT, THE TECH NOTICED A BURR ON THE THREAD, AND THE THREAD HAD STARTED TO PEEL. THE SURGEON REMOVED THE NUT AND COLLAR, AND REPLACED THEM WITH ANOTHER NUT AND COLLAR TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THIS IS REPORT 3 OF 3 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154397 10NM TORQUE WRENCH 11MM ACROSS THE FLATS HXC SYNTHES MONUMENT 0401

    Patients

    Seq Age Sex Outcome Treatment
    1