BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DRILL SLEEVE 2 W/SCALE F/DRILL BITS

    MDR report key: 2944870 · Received February 6, 2013

    Report

    Report Number
    8030965-2013-00339
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Report Date
    November 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION BASED TO THE MANUFACTURING AND MATERIAL DOCUMENTS HAS SHOWN THAT THE COMPLAINED ARTICLES WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS. ALL METALLIC CONTACTS IN DAMP OR WET CONDITIONS PRODUCE ELECTROLYTIC REACTION WITH CONTACT CORROSION AS RESULT, WHICH SHOULD BE AVOIDED. THE RUST RESISTANT TRACES CAN BE EASILY REMOVED. THEREFORE WE CAN DEFINE CLEARLY, THAT THIS IS AN ACCRETION OF CONTACT CORROSION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT TRACES OF CORROSION WERE FOUND. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50376 LCP DRILL SLEEVE 2 W/SCALE F/DRILL BITS LCP DRILL SLEEVE FZX SYNTHES GMBH 3765946

    Patients

    Seq Age Sex Outcome Treatment
    1