BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA-II BLADE L85 TAN

    MDR report key: 3181301 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03789
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    March 23, 2012
    Report Date
    March 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE ADDITIONAL EVALUATION REVEALED THE DEVICE SHOWED MARKS OF USE. THE FUNCTIONAL TEST COULD NOT IDENTIFY ANY DEVIATION TO THE SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED.

    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. THE DEVICE HISTORY RECORD REPORTS THE COMPLAINT TO BE INDETERMINATE, THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPACTING THE PFNA BLADE INTO THE PROPER POSITION, THE SURGEON WAS LOCKING THE BLADE BUT IT GAVE WAY AND WOULD NOT LOCK. THERE WAS NO MANIPULATION PRIOR TO IMPACT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282934 PFNA-II BLADE L85 TAN GFA SYNTHES GMBH 2826042

    Patients

    Seq Age Sex Outcome Treatment
    1