BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTRACT-SLEEVE Ø16 L277 F/PERCUT-INSERT

    MDR report key: 3141291 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02553
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    July 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQN
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICES WERE RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE ITEMS SHOW CORROSION TRACES OF WHICH, THE VISIBLE TRACES CAN BE EASILY REMOVED. THEREFORE, WE CAN CLEARLY ESTABLISH THAT IN THIS CASE IT CONCERNS AN ACCUMULATION OF CONTACT CORROSION. AS TO THE FORMING OF RUST, IN GENERAL IT CAN BE SAID THAT ALL MATERIALS, ALSO THE SO-CALLED STAINLESS STEELS, ARE ONLY FREE OF RUST UNDER CERTAIN CONDITIONS. CONCLUSION THE RUST RESISTANCE ONLY APPLIES THEN, WHEN THE MATERIAL IS DRY AND IS STORED FREE OF CONTACT WITH OTHER METALLIC OBJECTS. ALL METALLIC CONTACTS UNDER MOIST OR WET CONDITIONS GENERATE ELECTROLYTIC REACTIONS WITH CONTACT CORROSION AS A RESULT. THEREFORE, HERE WE ARE DEALING WITH NORMAL SIGNS OF WEAR AND TEAR. THERE ARE NO PRODUCT DEFECTS.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ACCORDING TO DOCTOR THERE ARE CORROSION TRACES ON THE BUSHES. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244973 DISTRACT-SLEEVE Ø16 L277 F/PERCUT-INSERT MQN SYNTHES GMBH 1679679

    Patients

    Seq Age Sex Outcome Treatment
    1