BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP DRILL SLEEVE 2.7 HEAD LCP2.4 W/SCALE

    MDR report key: 2905747 · Received January 9, 2013

    Report

    Report Number
    8030965-2013-00092
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 12, 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE US, BUT A SIMILAR DEVICE IS MARKETED IN THE US.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION NOT PREVIOUSLY REPORTED. THE INVESTIGATION OF THE COMPLAINED LCP DRILL SLEEVES HAS REVEALED THAT THESE REALLY SHOW TRACES OF CORROSION . THE VISIBLE TRACES CAN BE EASILY REMOVED. THEREFORE WE CAN DEFINE CLEARLY, THAT THIS IS AN ACCRETION OF CONTACT CORROSION. ACCORDING OF CORROSION CAN BE GENERALLY SAID, THAT ALL MATERIALS ALSO SO-CALLED STAINLESS STEELS ARE CONDITIONALLY RESISTANT TO RUST. THE RUST RESISTANT APPLIES ONLY IF THE MATERIAL IS STORED DRY AND IS FREE OF CONTACT WITH OTHER METAL OBJECTS. ALL METALLIC CONTACTS IN DAMP OR WET CONDITIONS PRODUCE ELECTROLYTIC REACTIONS WITH CONTACT CORROSION AS RESULT. THAT IS A NORMAL WEAR AND TEAR. DEVICE IS DISTRIBUTED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: RUST ON THE LABELING. THIS IS 4 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11970 LCP DRILL SLEEVE 2.7 HEAD LCP2.4 W/SCALE LCP DRILL SLEEVE 2.7 HEAD LCP2.4 W/SCALE FZX SYNTHES GMBH 1915013

    Patients

    Seq Age Sex Outcome Treatment
    1