BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER

    MDR report key: 3080590 · Received April 26, 2013

    Report

    Report Number
    1719045-2013-10933
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    October 30, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. IMPLANT DATE UNKOWN. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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 DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, THE SURGEON INSERTED THE TFN NAIL AND WAS INSERTING THE HELICAL BLADE AND IT WOULD NOT GO THROUGH. THE SURGEON PULLED OUT THE HELICAL BLADE AND PARTIALLY PULLED OUT THE NAIL, DISCOVERING THE LOCKING MECHANISM ON THE NAIL WAS IN THE DOWN POSITION. THE SURGEON BACKED UP THE SET SCREW, AND INSERTED THE NAIL AND THE HELICAL BLADE TO COMPLETE THE PROCEDURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181291 11MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER HSB SYNTHES MONUMENT 6699865

    Patients

    Seq Age Sex Outcome Treatment
    1