BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK FMS SHAVER/BURR

    MDR report key: 1197626 · Received October 13, 2008

    Report

    Report Number
    1221934-2008-00476
    Event Type
    Malfunction
    Date Received
    October 13, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 EVALUATED, THOSE RESULTS WILL BE THE SUBJECT OF A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ONE OF OUR QUALITY ENGINEERS IS REPORTING THAT DURING A SHOULDER REPAIR, THEY AND THE SURGEON NOTED THAT THERE WERE METAL SHAVINGS EMANATING FROM THE SHAVER. IT IS NOT KNOWN IF ALL OF THE DEBRIS WAS REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT. (OUR REP IN A CONVERSATION GOES ON TO REPORT THAT THEY OBSERVED THIS PHENOMENON IN 2 MORE SAME TYPE PROCEDURES WITH UNSPECIFIED FMS CUTTERS, SAME DAY WITH THE SAME SURGEON AT THE SAME FACILITY. SEE MDRS 1221934-2008-00474 AND 1211934-2008-00475).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK FMS SHAVER/BURR ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK UNK 0751B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK