BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L95 TAN

    MDR report key: 3130662 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02349
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    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. 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

    THE INSTRUMENT WAS SENT TO OUR RELEVANT PM FOR INVESTIGATION: THE BLADE IS COMPLETELY JAMMED UP AND COULD ONLY BE LOOSENED UP BY USING EXCESSIVE FORCE. THIS GIVES US A CLEAR INDICATION THAT THE PFNA BLADE HAS NOT BEEN INSERTED CORRECTLY, WRONG ROTATIONAL DIRECTION. THE END CAP OF THE BLADE WAS FOUND BROKEN. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. THE RETURNED ARTICLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS, AS WELL AS THE DEVICE HISTORY RECORD HAS BEEN RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013, THE PROXIMAL FEMORAL NAIL A (PFNA) BLADE STUCK TO THE BLADE INSERTER. THE SURGEON FOUND IT DIFFICULT TO LOCK THE BLADE AND RELEASE THE INSERTER. THE SURGEON DECIDED TO TAKE OUT THE BLADE AND PUT IN A NEW ONE. IT WAS REPORTED THAT BECAUSE THE SURGEON WAS UNABLE TO RELEASE THE BLADE FROM THE INSERTER, HE DECIDED TO BREAK THE BLADE TO GET THE INSERTER FREE. THE TIP OF THE BLADE REMAINED ATTACHED TO THE INSERTER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232482 PFNA BLADE PERF L95 TAN HSB SYNTHES GMBH 8253125

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR