BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II Ø9 SM 130° L200 TAN

    MDR report key: 3131664 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02449
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION AND INVESTIGATION COORDINATED BY SYNTHES (B)(4) REPORTS THE FOLLOWING: THE EXAMINATION OF THE RAW MATERIAL INSPECTION SHEETS AND THE MANUFACTURING PAPERS SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIAL IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS ISO (B)(4) AND ASTM (B)(4). BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE WEN CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO MODERATE DYNAMIC BENDING LOADS AND ASSUMABLE TORSIONAL LOADS TOO. CONSTANTLY ALTERNATING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD, RESPECTIVELY TO THE FATIGUE FRACTURE. THE IMPLANT COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD/FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT WAS IMPLANTED WITH A PROXIMAL FEMORAL NAIL A II (PFNA II). POST-OPERATIVELY, THE PFNA II NAIL WAS DISCOVERED BROKEN INSIDE THE PATIENTS FEMUR. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237381 PFNA-II Ø9 SM 130° L200 TAN HSB SYNTHES GMBH 2791744

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention