BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBINATION WRENCH Ø11

    MDR report key: 3141242 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02603
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXC
    PMA / PMN Number
    EXEMPT
    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. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. AN INSPECTION OF THE COMBINATION WRENCH SHOWED SOME VISIBLE TRACES OF RUST ON THE RESPECTIVE SURFACES. EVEN ORGANIC RESIDUES LIKE DRIED BLOOD ARE VISIBLE. THESE TRACKS CAN ARISE IF THE WRENCHES ARE NOT PROPERLY CLEANED, OR IF THEY ARE NOT DRIED AFTER CLEANING PROPERLY AND RUST FORMS DUE TO RESIDUAL MOISTURE ON SURFACE. HOWEVER, IT IS CLEAR THAT THE CHROMIUM LAYER IS BROKEN AT SEVERAL PLACES. THIS MEANS THAT RUST DID FORM. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. CONCLUSION BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES AND IS DUE TO THE CONDITIONS OF USE AND THAT THESE DEVICES WERE NOT MAINTAINED CORRECTLY. FURTHER WE MUST STATE THAT THESE WRENCHES CANNOT BE MADE COMPLETELY OF STAINLESS MATERIAL. A NEW COMBINATION WRENCH BETTER PROPERTIES WAS RELEASED TO THE MARKET AND IS CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RUST WAS OBSERVED AFTER A TREATMENT PROCESS. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244012 COMBINATION WRENCH Ø11 HXC SYNTHES GMBH 3632593

    Patients

    Seq Age Sex Outcome Treatment
    1