BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3070096 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10771
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 5, 2011
    Report Date
    December 15, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 LOCKING MECHANISM WAS IN THE FULL LOCKED POSITION; THE TAB HAS BEEN BROKEN OFF, AND WAS NOT RETURNED WITH THE NAIL. THERE ARE SOME SCRAPES IN THE ANODIZE INSIDE THE 11 MM HOLE. THE LOCKING MECHANISM ADVANCED AND RETRACTED WITH THE SCREWDRIVER BUT IS NOT FUNCTIONAL WITHOUT THE TAB. 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 BROKEN OFF AS A RESULT. THIS ISSUE HAS BEEN NOTED ON SEVERAL PREVIOUS COMPLAINTS AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. IT IS CONCLUDED THAT THIS COMPLAINT IS VALID. 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. ORIGINAL AWARENESS DATE IS (B)(4) 2011. ADDITIONAL INFORMATION WAS RECEIVED (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN PROCEDURE, THE SURGEON WAS INSERTING THE TFN NAIL ((B)(4)) INTO THE HELICAL BLADE, AND THE NAIL WOULD NOT ADVANCE. THE SURGEON THEN REALIZED THAT THE LOCKING POSITION OF THE TFN NAIL WAS DOWN AND DEPLOYED. SURGEON BACKED OUT TFN NAIL AND HELICAL BLADE. SURGEON SELECTED A NEW TFN NAIL AND RE-USED THE BLADE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. NO HARM TO PATIENT. THE TFN NAIL LOOKS DAMAGED AROUND THE LOCKING POSITION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172734 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER HSB SYNTHES MONUMENT 6634867

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR