BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L90 SST

    MDR report key: 3191225 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03255
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    January 26, 2012
    Report Date
    January 31, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    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. (B)(6). AGE AT TIME OF EVENT REPORTED INCORRECTLY IN INITIAL MW. PLACEHOLDER.

    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 DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE BLADE WAS RETURNED IN A LOCK POSITION. IT WAS FOUND THAT THE INNER SCREW GOT DAMAGED ON THE TOP EDGE OF THE HEAD AS WELL AS THE INNER HEXAGONAL PART IS BADLY DEFORMED. THEREFORE, IT IS NOT POSSIBLE TO REASSEMBLE THEM ANYMORE. WE CAN ONLY SUPPOSE THAT THE WRONG HANDLING, TIGHTENING UP IN THE WRONG DIRECTION HAS CAUSED THE JAMMING UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE WOULD NOT ATTACH TO SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290834 PFNA BLADE PERF L90 SST KTT SYNTHES GMBH 2762736

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR