BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL BURR, STERILE, 5.5MM

    MDR report key: 1706760 · Received May 24, 2010

    Report

    Report Number
    1221934-2010-00197
    Event Type
    Malfunction
    Date Received
    May 24, 2010
    Date of Event
    April 19, 2010
    Report Date
    May 17, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    NBH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION 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 AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE SURGEON OBSERVED METAL SHAVINGS EMANATING FROM 3 SUCCESSIVE FMS SHAVER BURRS AND FALLING INTO THE PATIENT'S JOINT SPACE. ALL OF THE DEBRIS WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. SEE ALSO ASSOCIATED MDRS 1221934-2010-00198 AND 00199.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARREL BURR, STERILE, 5.5MM ARTHROSCOPIC INSTRUMENT NBH DEPUY MITEK 287865 0815L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK