BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L90 TAN

    MDR report key: 3173085 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03144
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    December 9, 2010
    Report Date
    December 21, 2010
    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. ADDITIONAL PRODUCT CODE: HWC. (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. AN ADDITIONAL EVALUATION WAS PERFORMED AND THE REPORT STATES THE FOLLOWING: THE CARRIED OUT FUNCTIONAL TESTS COULD NOT IDENTIFY ANY DEVIATIONS TO THE SPECIFICATIONS. DEVICE WAS DISASSEMBLED AND WAS FOUND TO BE IN CONFORMANCE WITH TECHNICAL DRAWINGS AND SPECIFICATIONS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED; THE BLADE WOULD NOT LOCK. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273074 PFNA-II BLADE L90 TAN HSB SYNTHES GMBH 2546770

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR