BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE L95 TAN

    MDR report key: 3171637 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03304
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    September 9, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE END CAP IS TWISTED IN THE COVER AND THE OUTER DIAMETER OF THE END CAP IS DAMAGED. THE INNER THREAD OF THE END CAP IS DAMAGED WHICH POSSIBLY INDICATE THAT THE BLADE WAS NOT CORRECTLY MOUNTED ON THE INSTRUMENT DURING THE INSERTION. ALTHOUGH THE BLADE IS DAMAGED, A FUNCTION TEST WAS POSSIBLE AND THE DEVICE WORKED AS REQUIRED. THE MEASURABLE DIMENSIONS OF THE PFNA BLADE WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED. 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

    THE BLADE COULD NOT BE INSERTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272513 PFNA BLADE L95 TAN HSB SYNTHES GMBH 2697053

    Patients

    Seq Age Sex Outcome Treatment
    1