BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 2983105 · Received February 28, 2013

    Report

    Report Number
    1719045-2013-10216
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    March 8, 2012
    Report Date
    March 8, 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. PLACEHOLDER.

    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. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HWC. ORIGINAL AWARENESS DATE IS 3/8/12.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN)-RIGHT, THE BLADE WOULD NOT PASS THROUGH THE NAIL. THE SURGEON REMOVED THE NAIL AND USED A DIFFERENT NAIL WITH THE SAME BLADE AND IT PASSED THROUGH WITH NO PROBLEM. THE NAIL IS AVAILABLE FOR RETURN. PATIENT WAS NOT HARMED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87914 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE HSB SYNTHES MONUMENT 6766946

    Patients

    Seq Age Sex Outcome Treatment
    1