BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL GUIDE WITH GRADUATION

    MDR report key: 3003449 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10266
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 FROM SYNTHES AND TELEFLEX (MANUFACTURER) WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. AS RECEIVED, THE INSTRUMENT LOCKED AND STAYED IN PLACE. AS RECEIVED, THE INSTRUMENT LOCKED AND STAYED IN PLACE. THE DEVICE PASSED FUNCTION TESTING IN BOTH THE LOCKED AND UNLOCKED POSITION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. BASED ON THE EVALUATION PERFORMED, THE REPORTED FAILURE WAS NOT ASSOCIATED WITH THE MANUFACTURING PROCESS; THEREFORE, THE EXACT CAUSE IS INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SYNAPSE CASE, THE DRILL GUIDE WAS SET AT 16MM AND WHILE DRILLING, IT ADVANCED TO 20MM. THERE WERE NO INJURY OR COMPLICATIONS TO THE PATIENT. ANOTHER DRILL GUIDE WAS USED FROM THE AXON TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87165 DRILL GUIDE WITH GRADUATION FZX SYNTHES MONUMENT 608138E09

    Patients

    Seq Age Sex Outcome Treatment
    1