BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE Ø1.6 W/THREAD-TIP W/TROCAR L15

    MDR report key: 3193207 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03764
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 13, 2012
    Report Date
    April 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LRN
    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. (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 TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH OR STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH SPECIFICATIONS AND THE INTERNATIONAL STANDARDS. THE MEASURABLE DIMENSIONS OF THE BROKEN GUIDE WIRE WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATIONS. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHICH INDICATES MATERIAL CONFORMITY TO THE SPECIFICATIONS AS WELL. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE BROKE UP DURING INSERTION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292306 GUIDEWIRE Ø1.6 W/THREAD-TIP W/TROCAR L15 LRN SYNTHES GMBH 7709330

    Patients

    Seq Age Sex Outcome Treatment
    1