BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L90 TAN

    MDR report key: 3183088 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03773
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    November 16, 2011
    Report Date
    December 5, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE ITEM HAS BEEN PASSED TO OUR PRODUCT DEVELOPMENT ENGINEER FOR INVESTIGATION. FUNCTIONAL TESTING COULD NOT IDENTIFY ANY DEVIATION TO THE SPECIFICATIONS. AFTER DISASSEMBLING, ALL PARTS WERE FOUND IN FAULTLESS CONDITION. THEREFORE WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH LED TO THIS REPORTED PROBLEM. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE COULD NOT BE LOCKED. THE PFNA SYSTEM WAS ATTEMPTED TO BE USED IN A CASE OF FEMORAL TROCHANTERIC FRACTURE AND INTRA-OSSEOUS FIXATION. WHEN LOCKING THE BLADE END AFTER THE INSERTION THE LOCK DID NOT WORK AND THE INSERTER CAME OFF. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283489 PFNA-II BLADE L90 TAN HSB SYNTHES GMBH 2785623

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR