BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA BLADE PERF L95 SST

    MDR report key: 3130633 · Received May 24, 2013

    Report

    Report Number
    2520274-2013-02820
    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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE RESULTS OF THE MANUFACTURING EVALUATION ARE AS FOLLOWS: BASED ON THE RMS REPORT THE NAIL 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. NO FAULT AT THE BLADE COULD BE DETECTED. CONTACT NAME CHANGED TO(B)(6) MANAGER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATES OF X-RAYS PROVIDED. ADDITIONAL CODE: HWC. 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. MANUFACTURER DETERMINED FROM LOT NUMBER RECEIVED. BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.

    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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231555 PFNA BLADE PERF L95 SST HSB SYNTHES GMBH 2792517

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention