BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA-II BLADE L100 TAN

    MDR report key: 3063856 · Received April 17, 2013

    Report

    Report Number
    8030965-2013-01688
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 19, 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 DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE PASSED THE REQUIRED FUNCTIONAL TEST SUCCESSFULLY. THE FAILURE AS PER EVENT DESCRIPTION COULD NOT BE DUPLICATED. THE PFNA-II BLADE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE FEMORAL NAIL ANTIROTATION (PFNA) II BLADE FAILED TO LOCK INTRA-OPERATIVELY. ANOTHER PFNA BLADE WAS USED AND ATTACHED TO THE SAME IMPACTOR (FOR PFNA BLADE), AND THE BLADE LOCKED AS PER THE LOCKING MECHANISM. IT WAS REPORTED THE SURGERY WAS PROLONGED FOR APPROXIMATELY TEN MINUTES WITH NO FURTHER INCIDENTS. THIS REPORT IS FOR A PFNA-II BLADE L100 TAN. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164205 PFNA-II BLADE L100 TAN HSB SYNTHES GMBH 8061348

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention