BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUNTERTORQUE WRENCH FOR CSLP

    MDR report key: 3724007 · Received April 3, 2014

    Report

    Report Number
    1719045-2014-10116
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 11, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE REVIEW OF DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: A COUNTERTORQUE WRENCH FOR CERVICAL SPINE LOCKING PLATE (CSLP) (324.067 LOT U129964) WAS RECEIVED WITH ONE OF THE FOUR PRONGS ON THE DISTAL TIP BROKEN OFF ABOVE THE RADIUS. OTHERWISE THE COUNTERTORQUE WRENCH IS IN GOOD CONDITION WITH MINIMAL WEAR PRESENT. DRAWINGS FOR THE COUNTERTORQUE WRENCH WERE REVIEWED AND FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE WRENCH WAS FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. A STRENGTH ANALYSIS WAS CONDUCTED TO DETERMINE THE FORCE REQUIRED TO SHEAR OFF A PRONG ABOVE THE RADIUS, WHICH EXISTS APPROXIMATELY HALFWAY DOWN THE LENGTH OF THE PRONG. TENSILE STRENGTH (MPA) FOR THE COUNTERTORQUE WRENCH¿S MATERIAL (440A STAINLESS STEEL) WAS USED WITH THE VON MISES CRITERION COEFFICIENT (0.577) TO CALCULATE THE MATERIAL¿S ULTIMATE SHEAR STRENGTH (MPA). THAT VALUE, THE MAXIMUM DISTANCE TO THE NEUTRAL AXIS, C (MM), AND POLAR MOMENT OF INERTIA, J (MM^4) WERE USED TO CALCULATE THE FORCE REQUIRED TO SHEAR OFF A PRONG ABOVE THE RADIUS. THE FORCE REQUIRED TO SHEAR ONE PRONG OFF OF THE COUNTERTORQUE WRENCH ABOVE THE RADIUS IS 0.65 NM OR APPROXIMATELY 0.48 FT-LBS OF TORQUE. IT IS LIKELY THAT THE WRENCH WAS NOT FULLY SEATED WITHIN THE EXPANSION-HEAD SCREW WHEN THE LOCKING SCREW WAS BEING INSERTED. THE RESULTING TORQUE WAS ENOUGH TO SHEAR OFF THE PRONG ABOVE THE RADIUS WHERE THE FORCE REQUIRED FOR FAILURE IS APPROXIMATELY 25% OF THAT OF A FULLY SEATED PRONG (2.61 NM). AFTER REVIEWING THE RELATED PRODUCT DRAWINGS, COMPLAINT HISTORY AND RISK ANALYSIS, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT IS THEREFORE CONFIRMED. IT IS LIKELY THAT THE DISTAL TIP OF THE COUNTERTORQUE WRENCH WAS NOT FULLY SEATED IN THE EXPANSION-HEAD SCREW WHEN THE LOCKING SCREW WAS INSERTED. THE RESULTING TORQUE WAS SUFFICIENT TO BREAK THE TIP OFF OF ONE OF THE PRONGS. THE DEVICE IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ONE OF THE TEETH WAS BROKEN OFF AND MISSING FROM THE GUIDE WHILE INSPECTING THE INSTRUMENT PRIOR TO A CASE. THE PATIENT INFORMATION IS NOT PROVIDED AS THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201893 COUNTERTORQUE WRENCH FOR CSLP WRENCH HXC SYNTHES MONUMENT U129964

    Patients

    Seq Age Sex Outcome Treatment
    1