BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VC SIZ 1/1 LCP COMPACT SM-FRAGM-INSTRSET

    MDR report key: 3171652 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02973
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    March 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ADDITIONAL INFO: (B)(4). DEVICE HISTORY RECORD REVIEW: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 A DEVICE MARKETED IN THE USA. THE EXAMINATION SHOWED THAT TRACES OF CORROSION FORMED ON DIFFERENT HOLDING SHEETS. THERE ARE SPOTS FROM DETERGENT THAT CAN BE SEEN ON THE SURFACE. THE VISIBLE TRACES CAN BE EASILY REMOVED MECHANICALLY. THUS, WE CAN CLEARLY SEE THAT THIS DEALS WITH A DEPOSIT OF CONTACT CORROSION. IN REGARDS TO THE FORMATION OF RUST, IT CAN BE SAID IN GENERAL THAT ALL MATERIALS, ALSO SO CALLED STAINLESS STEEL, ARE ONLY CONDITIONALLY RESISTANT TO RUST. THE RESISTANCE TO RUST ONLY APPLES IF THE MATERIAL IS STORED DRY AND DOES NOT COME IN CONTACT WITH OTHER METALLIC OBJECTS. ALL METALLIC CONTACT UNDER MOIST OR WET CONDITIONS CREATES ELECTROLYTIC REACTIONS WITH CONTACT CORROSION AS A RESULT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, THE VARIO CASE WAS OBSERVED TO HAVE DISCOLORATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272524 VC SIZ 1/1 LCP COMPACT SM-FRAGM-INSTRSET FSM SYNTHES GMBH 1630870

    Patients

    Seq Age Sex Outcome Treatment
    1