BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USS-II NUT TAN GREEN

    MDR report key: 3171188 · Received June 14, 2013

    Report

    Report Number
    8030965-2013-03338
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    October 7, 2011
    Report Date
    November 28, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT WE HAVE ANALYZED THE COMPLAINED PARTS AT MANUFACTURING SIDE AND FOUND THAT THEY FULLY MEET THE PRINT SPECIFICATIONS. ALL MEASURABLE DIMENSIONS ARE WITHIN SPECIFICATION. THE VISIBLE SIGNS ON THE THREAD INDICATE CROSS-THREADING WHICH MAY HAVE CAUSED WIDENING OF THE SHAT-LIKE SECTION OF THE NUTS. WE CLASSIFY THIS AS MANIPULATION PROBLEMS DURING USE. THIS PROBLEM MAINLY OCCURS WHEN THE SURGEON TRIES TO INSTALL THE NUT WITHOUT USING USS II POLY SCREW HOLDER 03.607.005 FOR GUIDANCE OF THE SOCKET WRENCH TO PROPERLY ALIGN THE NUT OR THE USS II POLY SCREW HOLDER HAS BEEN INSTALLED INCORRECTLY CAUSING MISALIGNMENT OF THE SCREW HOLDER RESULTING IN CROSS-THREADING OF THE NUT. A CAPA DETERMINATION REQUEST HAS BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NUTS COULD NOT BE FIXED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271305 USS-II NUT TAN GREEN HWC SYNTHES GMBH 3491549

    Patients

    Seq Age Sex Outcome Treatment
    1