BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX ST FEMORAL GUIDE FRAME

    MDR report key: 1885048 · Received October 20, 2010

    Report

    Report Number
    1221934-2010-00384
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 15, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    NBH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT THE SURGEON OBSERVED METAL SHAVINGS FALLING INTO THE PT'S JOINT SPACE WHILE A RIGIDFIX GUIDE FRAME WAS BEING USED. ALL OF THE DEBRIS WAS REMOVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIDFIX ST FEMORAL GUIDE FRAME ARTHROSCOPIC INSTRUMENT NBH DEPUY MITEK 213701 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK