BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMA BARREL BUR, 4.0MM

    MDR report key: 1034944 · Received April 25, 2008

    Report

    Report Number
    1221934-2008-00211
    Event Type
    Malfunction
    Date Received
    April 25, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT IN TIME, MITEK IS IN THE INFO GATHERING MODE, AND IS AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING ROOT CAUSE FAILURE ANALYSIS. WHEN ALL OF THIS IS DONE, THE RESULTS OF THE INVESTIGATION WILL BE THE SUBJECT OF THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING THAT DURING A SHOULDER REPAIR, THE SURGEON NOTED THAT THERE WERE METAL SHAVINGS EMANATING FROM THE SHAVER. THIS IS ALL OF THE INFO THAT HAS AT THIS POINT IN TIME BEEN GIVEN TO MITEK, QUESTIONS OUT TO OUR AFFILIATE FOR CLARITY AND FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMA BARREL BUR, 4.0MM SURGICAL INSTRUMENT HTT DEPUY MITEK 287760 7520F0648

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK