BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø10 LONG LE 130° L380 SST

    MDR report key: 3130632 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02344
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 27, 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 IS USED FOR TREATMENT, NOT DIAGNOSIS.

    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. THE 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE RESULTS OF THE ADDITIONAL EVALUATION ARE AS FOLLOWS: THE EXAMINATION OF THE RAW-MATERIAL INSPECTION SHEET AND THE MANUFACTURING DOCUMENTS SHOWED NO DEVIATION IN RELATION TO THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES. THE MATERIAL IS IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS. THE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING AND AO/ASIF SPECIFICATION. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO DYNAMIC BENDING TORSIONAL LOADS. CONSTANTLY ALTERNATING BENDING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE. THE NAIL COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. DATE OF EVENT WAS INCORRECTLY REPORTED ON INITIAL. DATE OF EVENT IS UNKNOWN (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PROXIMAL FEMORAL NAIL A (PFNA) IMPLANTED ON AN UNKNOWN DATE IN (B)(6) 2012 NEEDED TO BE TAKEN OUT DUE TO SNAPPED PROSTHESIS. THE PFNA HAD COMPLETELY SNAPPED AT THE POINT OF THE BLADE. X-RAYS LOOKED LIKE THE BONE WAS NOT REDUCED PROPERLY ON FIRST IMPLANT AND SO THE DEVICE BECAME LOAD BEARING. THE REVISION TOOK PLACE ON (B)(6) 2013. IT WAS REPORTED THAT THERE WERE MARKS ON THE PFNA BLADE THAT MAY HAVE BEEN CAUSED BY INCORRECT INSERTION OF THE BLADE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232453 PFNA Ø10 LONG LE 130° L380 SST HSB SYNTHES GMBH 7954361

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention