BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER

    MDR report key: 3063725 · Received April 17, 2013

    Report

    Report Number
    1719045-2013-10699
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    October 12, 2011
    Report Date
    October 12, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    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 TFN PROCEDURE, THE SURGEON HAD DIFFICULTY GETTING THE BLADE TO GO THROUGH THE NAIL. SURGEON REMOVED BLADE AND DISCOVERED THAT THE LOCKING MECHANISM WAS IN THE LOCK POSITION. SURGEON ADJUSTED THE MECHANISM WITH A DRIVER, REINSERTED THE BLADE AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SALES CONSULTANT NOTICED THAT THE LOCKING MECHANISM WAS IN THE DOWN POSITION OUT OF THE PACKAGE. NO ADVERSE EFFECT ON PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PROCEDURE WAS REPORTED TO BE TROCHANTERIC FIXATION NAIL (TFN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164473 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER HSB SYNTHES MONUMENT 6676056

    Patients

    Seq Age Sex Outcome Treatment
    1