BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONELEVER SHORT NARROW TIP W/18 L235

    MDR report key: 3157883 · Received June 10, 2013

    Report

    Report Number
    8030965-2013-02978
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    July 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    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. 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. 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 DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE EXAMINED BONE LEVERS DETERMINED THAT THESE DEVICES DID INDEED EXHIBIT SIGNS OF CORROSION. THE VISIBLE TRACES WERE EASILY REMOVED MECHANICALLY. THE MEASURABLE DIMENSIONS WERE CHECKED TO THE EXTENT THAT THEY COULD BE. IT WAS DETERMINED THAT THESE DIMENSIONS CORRESPONDED TO THE DRAWINGS AND THE AO/ASIF SPECIFICATIONS. NO PRODUCT ERROR COULD BE DETERMINED AND THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. WE CLEARLY DETERMINED THAT THIS EVENT INVOLVED ABSORPTION OF CONTACT CORROSION. WITH REGARD TO THE BUILD-UP OF RUST, IT CAN BE GENERALLY SAID THAT ALL MATERIALS, EVEN SO-CALLED STAINLESS STEEL, ARE ONLY CONDITIONALLY RESISTANT TO RUST. THE RESISTANCE TO RUST ONLY APPLIES IF THE MATERIAL IS STORED DRY AND WITHOUT CONTACT WITH OTHER METALLIC OBJECTS. ALL METALLIC CONTACT UNDER MOIST OR WET CONDITIONS GENERATES ELECTROLYTE REACTIONS, WITH CONTACT CORROSION AS A RESULT. IN THIS CASE, IT THEREFORE INVOLVES A NORMAL APPEARANCE OF WEAR AND TEAR. CONCLUSION ¿IT WAS CLEARLY DETERMINED THAT THESE DEVICES DID INDEED EXHIBIT SIGNS OF CORROSION AND WE CLASSIFY THIS OCCURRENCE AS CONTACT CORROSION AND THEREFORE INVOLVES A NORMAL APPEARANCE OF WEAR AND TEAR. THE RESISTANCE TO RUST ONLY APPLIES IF THE MATERIAL IS STORED DRY AND WITHOUT CONTACT WITH OTHER METALLIC OBJECTS SO THE COMPLAINT CONDITION IS RELATED TO THE STORAGE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN EMERGENCE OF CORROSION. AFTER A ONE-TIME TREATMENT THERE WAS AN EMERGENCE OF CORROSION ON THE SURFACE COATING. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259749 BONELEVER SHORT NARROW TIP W/18 L235 HSB SYNTHES GMBH 5915723

    Patients

    Seq Age Sex Outcome Treatment
    1