BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HANDLE T2 TIBIA

    MDR report key: 2945756 · Received January 4, 2013

    Report

    Report Number
    9610622-2013-90007
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 17, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE REPORTED EVENT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY AND A REVIEW OF THE RISK ANALYSIS DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS WERE REQUIRED AT THIS TIME. EVAL AND APPEARANCES OF THE DAMAGES SUGGEST THAT THE DEVICES BECAME DAMAGED DUE TO FRETTING CORROSION. HIGH SURFACE PRESSURE WAS ASSUMED WHICH CAN BE CAUSED BY MISALIGNED ASSEMBLY AND / OR BY FOREIGN SUBSTANCES BETWEEN THE AFFECTED PARTS. WITH AVAILABLE INFO A REAL CAUSE COULD NOT BE DETERMINED. (B)(4) NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM LOT# UNK; (B)(4) TIBAL NAIL, STANDARD T2 TIBIA ?12X360 MM LOT# K644789.

    Description of Event or Problem · 1

    OUR SALES REP REPORTED TO US THAT DURING A TRAINING HE OBSERVED THAT IT WAS NOT POSSIBLE TO SEPARATE THE DEVICES ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5846 NAIL HANDLE T2 TIBIA INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KHI041047

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other