BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUNTERTORQUE WRENCH FOR CSLP

    MDR report key: 3071417 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10840
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 30, 2012
    Report Date
    July 30, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. MANUFACTURING EVALUATION REPORTS THE PART WAS RECEIVED FOR EVALUATION AND IT WAS NOTED THAT THE TABS ON THE BIT WERE BROKEN OFF. THE COMPLAINT PRODUCT MET DIMENSIONAL SPECIFICATIONS AND THE MATERIAL AND HARDNESS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. THE BIT WAS DAMAGED. THE TABS WERE BROKEN OFF AND THE DIMENSIONS COULD NOT BE MEASURED. THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED SYNTHES INCOMING INSPECTION. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE UNKNOWN ROOT CAUSE, AND THE EVALUATION CONDUCTED BY SYNTHES, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACDF (ANTERIOR CERVICAL DECOMPRESSION AND FIXATION) PROCEDURE, WHILE USING ONE OF THE TABS ON THE COUNTER, THE TORQUE SNAPPED OFF. THE SURGEON SELECTED ANOTHER ONE OF THE SAME TORQUE TYPE FROM THE BACK-UP SET AND FOUND THAT TWO OF THE TABS WERE ALREADY BROKEN OFF FROM THE BACK-UP TORQUES. THE BREAKAGE HAD OCCURRED SOMETIME PRIOR TO THIS PARTICULAR PROCEDURE. A THIRD TORQUE WAS USED WITHOUT FURTHER INCIDENT AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENT TO THE PATIENT. THIS REPORT IS 1 OF 2 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171458 COUNTERTORQUE WRENCH FOR CSLP HXC SYNTHES MONUMENT U115892

    Patients

    Seq Age Sex Outcome Treatment
    1