BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL/TAP AND SCREW GUIDE

    MDR report key: 3003335 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10253
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. MANUFACTURING EVALUATION REVEALED THAT THE DEVICE WAS RETURNED WITH THE POSITIONING PIN OF THE GUIDE MISSING. VISUAL INSPECTION SHOWED THAT THE PIN FELL OUT, AS REPORTED. THE FRACTURE FACE OF THE WELD WAS HOMOGENEOUS, INDICATING MATERIAL CONFORMITY. IT IS POSSIBLE THAT TOO MUCH LATERAL STRESS WAS APPLIED ONTO THE GUIDE, CAUSING THE WELD OF THE PIN TO BREAK; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE POSITIONING PIN WAS NOT RETURNED. THE COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ACDF C5-C6 PROCEDURE, THE FOOT ON THE DRILL AND SCREW GUIDE FELL OFF. THE PIECES WERE RETRIEVED AND THE SURGEON SELECTED ANOTHER GUIDE TO COMPLETE PROCEDURE. NO HARM TO THE PT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87404 DRILL/TAP AND SCREW GUIDE FZX SYNTHES GMBH 1445719

    Patients

    Seq Age Sex Outcome Treatment
    1