BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3057053 · Received April 14, 2013

    Report

    Report Number
    1719045-2013-10665
    Event Type
    Malfunction
    Date Received
    April 14, 2013
    Report Date
    June 27, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HWC. IMPLANT DATE - (B)(6) 2011. 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. HOWEVER, THIS ISSUE HAS BEEN NOTED ON PREVIOUS COMPLAINTS AND AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    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)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL CASE, THE SURGEON WAS IMPLANTING THE NAIL, AND THE HELICAL BLADE WAS NOT ADVANCING. HE DISCOVERED THAT THE SET SCREW IN THE NAIL WAS ALREADY SEATED. THE SURGEON REMOVED THE BLADE WITH THE REMOVAL INSTRUMENT, BACKED THE SETSCREW OUT, AND REINSERTED THE BLADE. THERE WERE NO FURTHER COMPLICATIONS AND THE NAIL WAS SUCCESSFULLY IMPLANTED. SURGERY TIME WAS EXTENDED BY 10 - 15 MINUTES. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160008 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE HSB SYNTHES MONUMENT 6661277

    Patients

    Seq Age Sex Outcome Treatment
    1