BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT

    MDR report key: 3051868 · Received April 10, 2013

    Report

    Report Number
    1719045-2013-10654
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    October 3, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION SHOWED THAT THE INSTRUMENT HAS LOCALIZED CORROSION PRESENT. THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE. THE EPOXY ON THE DRILL GUIDE IS EITHER MISSING OR DEGRADED. THERE HAVE BEEN NO OTHER NON-CONFORMANCES FOR CORROSION FOR THIS INSTRUMENT AND NO OTHER PARTS FOR THESE LOTS IN QUESTION HAVE BEEN RETURNED. THERE ARE NO NONCONFORMING FEATURES ON THE DEVICE EXCEPT FOR THE CORROSION NOTED. BASED ON THESE DETERMINATIONS THIS REPORTED FAILURE IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESSES. THEREFORE, BASED ON THE EVALUATION AND THE UNKNOWN ROOT CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL GUIDES (388.393 AND 03.614.011) ARE RUSTING, THE TORQUE LIMITING HANDLE (30.614.035) DO NOT WORK PROPERLY, THE ROD CUTTER (03.614.021) HAS A DULL BLADE AND DOES NOT CUT WELL, THE PERSUADER (03.614.027) IS RUSTING, THE QUICK COUPLING HANDLES (324.107) ARE RUSTY, AND THE DEPTH GAUGE (03.161.028) IS BROKEN. THIS IS REPORT 1 OF 6 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 6 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153479 DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT FZX SYNTHES MONUMENT 571963A07

    Patients

    Seq Age Sex Outcome Treatment
    1