BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II Ø9 XS 130° L170 TAN

    MDR report key: 3183616 · Received June 22, 2013

    Report

    Report Number
    2520274-2013-03573
    Event Type
    Injury
    Date Received
    June 22, 2013
    Date of Event
    January 6, 2011
    Report Date
    January 25, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. METHOD: VISUAL INSPECTION, MANUFACTURING RECORD REVIEW, RESULTS - VISUAL INSPECTION ¿ THE BLADE BACKED OUT ONE YEAR AFTER INSERTION AND THE PRODUCT WAS RETURNED AND INSPECTED. THE MEASURABLE DIMENSIONS OF THE DEVICE WERE CHECKED AND FOUND TO BE IN COMPLIANCE. MANUFACTURING RECORD REVIEW - A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. CONCLUSION: WHILE THE SURGEON THINKS THAT THE BLADE BACK OUT WAS DUE TO A PRODUCT FAILURE AS HE COULD STILL PULL THE BLADE EVEN WHEN THE HELICAL PART WAS FIXED, THE INVESTIGATION DETERMINED THAT NO PRODUCT FAULT COULD BE DETECTED. NO DISCREPANCIES WERE NOTED AND THE COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED IN (B)(6) THAT THE PATIENT HAD A FEMORAL BOND FRACTURE AND WAS TREATED WITH A (B)(6) PROXIMAL FEMORAL NAIL ANTIROTATION, ON (B)(6) 2009 WITHOUT ANY PROBLEM AND THE PATIENT APPEARED HEALED. LIKEWISE, ON (B)(6) 2010, AT THE DOCTOR'S ASSESSMENT, THERE WAS NO PROBLEM AND THE BONE LOOKED HEALED. HOWEVER, AFTER ONE YEAR LATER, THE BLADE BACKED OUT AND THE SUPPORT OF THE FEMORAL HEAD WAS LOST. THIS RESULTED IN A MEDIAL BONE FRACTURE. ON (B)(6) 2011, THE PATIENT WAS REVISED. THE DOCTOR REMOVED THE JPFNA, AND USED AN ARTIFICIAL JOINT. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE SECOND REPORT OF TWO FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284417 PFNA-II Ø9 XS 130° L170 TAN HRS SYNTHES (USA) 2410876

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention