BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER

    MDR report key: 3002506 · Received March 13, 2013

    Report

    Report Number
    1719045-2013-10339
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 4, 2012
    Report Date
    January 4, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A TROCHANTERIC FIXATION NAIL (TFN), AFTER THE NAIL WAS INSERTED, SURGEON INSERTED THE HELICAL BLADE AND IT WOULD NOT ADVANCE INTO THE NAIL (456.481S). SURGEON BACKED OUT THE HELICAL BLADE AND TRIED TO RE-INSERT THE BLADE INTO THE NAIL BUT IT WOULD NOT ADVANCE. SURGEON THEN USED A NEW SET OF INSTRUMENTS BUT THE BLADE WOULD NOT ADVANCE INTO THE NAIL. SURGEON BACKED OUT THE BLADE AND NAIL. THE LOCKING POSITION WAS UP AND NOT DEPLOYED. SURGEON USED A NEW NAIL AND THE HELICAL BLADE ADVANCE INTO THE NAIL WITH NO PROBLEMS. SURGEON HAD TO RE-DRILL THE HOLE AND USED THE REAMER AGAIN FOR THE NEW NAIL. PROCEDURE WAS COMPLETED WITH NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104971 12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER HSB SYNTHES MONUMENT 6713656

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR