BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROMIOBLASTER, 4.0 MM, EP-1, DISP BURR

    MDR report key: 1250759 · Received December 2, 2008

    Report

    Report Number
    1219602-2008-00254
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Report Date
    November 3, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DOCTOR WAS USING THE BURR ON AN ANKLE SCOPE, AND THE BURR STARTED SHEDDING ALL OVER THE JOINT. THE WHOLE SCREEN WAS SILVER FROM ALL THE FLAKES. HE SAID HE WAS NOT PUTTING A LOT OF TORQUE ON IT. HE WAS ABLE TO FLUSH SOME SHAVINGS OUT BUT NOT ALL OF THEM. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROMIOBLASTER, 4.0 MM, EP-1, DISP BURR ACROMIOBLASTER BURR HTT SMITH & NEPHEW INC., ENDOSCOPY DIV. 7205668 20062661

    Patients

    Seq Age Sex Outcome Treatment
    1