BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM

    MDR report key: 3071872 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10857
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    November 20, 2011
    Report Date
    November 20, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    NURSE

    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 PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE NAIL WAS RECEIVED WITH THE LOCKING MECHANISM AND THE RETENTION SCREW FOR THE LOCKING MECHANISM REMOVED FROM THE NAIL. THE BLADE WAS BROKEN OFF THE LOCKING MECHANISM AND THE FRAGMENT WAS ALSO RETURNED. THE BLADE IS TWISTED AND HAD A LARGE GOUGE ACROSS THE INSIDE SURFACE. BASED ON EXAMINATION OF THE RETURNED PART, THE LOCKING MECHANISM WAS IN THE LOCKED POSITION WHEN ATTEMPTING TO INSERT THE HELICAL BLADE. THE LOCKING TAB WAS BENT AND THEN BROKEN OFF AS A RESULT. THIS ISSUE HAS BEEN NOTED ON SEVERAL PREVIOUS COMPLAINTS AND AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. THIS COMPLAINT IS VALID AND IS BEING ADDRESSED. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HWC.

    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN INTERTROCHANTERIC FRACTURE WAS BEING IMPLANTED WITH A TFN, AND WHEN THE SURGEON WAS INSERTING THE NAIL HE REALIZED THE LOCKING MECHANISM WAS ALREADY ENGAGED AND THE HELICAL BLADE BECAME JAMMED. SURGEON REMOVED BLADE AND NAIL AND SAW THAT THE ROTATIONAL DEVICE WAS SHEARED OFF. SURGEON SELECTED A NEW NAIL AND SAME HELICAL BLADE AND RE-INSERTED EVERYTHING WITH SUCCESS. THERE WAS NO HARM TO THE PATIENT. HOSPITAL IS IN POSSESSION OF NAIL AND WILL BE RETURNING IT. 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
    171637 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM HSB SYNTHES (USA) 6777346

    Patients

    Seq Age Sex Outcome Treatment
    1