BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USS-II SLEEVE TOOTHED F/R Ø6 TAN VIOL

    MDR report key: 3192683 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03566
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    August 15, 2011
    Report Date
    October 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE EXAMINATION OF THE RAW MATERIAL CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATION REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH THE SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARDS. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE MEASURABLE DIMENSIONS OF THE BROKEN USS-II SLEEVE WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATIONS. THE BROKEN SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USS II SLEEVE BROKE DURING IMPLANTATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292021 USS-II SLEEVE TOOTHED F/R Ø6 TAN VIOL MNI SYNTHES GMBH 3267432

    Patients

    Seq Age Sex Outcome Treatment
    1