BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L95 TAN

    MDR report key: 3171620 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02713
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    March 10, 2011
    Report Date
    March 22, 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. 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION OF THE COMPLAINED DEVICE COULD NOT IDENTIFY THE ROOT CAUSE FOR THE REPORTED PROBLEM. THE CARRIED OUT FUNCTIONAL TEST COULD NOT IDENTIFY ANY DEVIATION TO THE SPECIFICATIONS. AFTER DISASSEMBLING, ALL PARTS WERE FOUND IN FAULTLESS CONDITIONS. PRODUCT FAULT WAS NOT FOUND. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING THE SURGICAL OPERATION THE SURGEON COULD NOT TIGHTEN THE HELICAL COMPRESSION BLADE. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272853 PFNA-II BLADE L95 TAN HSB SYNTHES GMBH 2546553

    Patients

    Seq Age Sex Outcome Treatment
    1