BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP F/CORTSCR Ø4.5 L125/70

    MDR report key: 3192629 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03538
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 2, 2011
    Report Date
    June 24, 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. (B)(6). 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 VALUES WERE IN COMPLIANCE WITH SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARDS. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHAT INDICATES MATERIAL CONFORMITY AS WELL. WE HAVE TO ASSUME THAT EXCEEDING APPLIED MECHANICAL FORCE, MOST LIKELY IN SLANTING DIRECTION, MAY HAVE CAUSED THE BREAKAGE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TAP WAS BROKEN DURING USE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292544 TAP F/CORTSCR Ø4.5 L125/70 HWC SYNTHES GMBH 2358013

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR