BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTED ATTACHMENT 2.4MM LEGENT, AF02 (B-1)

    MDR report key: 1084258 · Received July 30, 2008

    Report

    Report Number
    1625507-2008-00046
    Event Type
    Malfunction
    Date Received
    July 30, 2008
    Report Date
    July 1, 2008
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMMENTS: REPORT CONFIRMED ON EVAL. NO ADD'L INFO WAS AVAILABLE ON F/U. THE USER MANUAL STATES "THE ATTACHMENT SHOULD NOT BE USED IF ANY PART OF THE ATTACHMENT APPEARS TO BE BENT, LOOSE, MISSING, OR DAMAGED. EXCESSIVE PRESSURE OR IMPROPER HANDLING, SUCH AS BENDING OR PRYING, OF THE ATTACHMENT OR DISSECTING TOOL MAY CAUSE INJURY TO THE PT, OPERATOR AND/OR OPERATING ROOM STAFF."

    Description of Event or Problem · 1

    REPAIR REQUEST INITIATED AND ESCALATED TO COMPLAINT FOR DEVICE WITH A REPORT OF DETACHED FOOT. NO PT IMPACT WAS REPORTED. NO ADD'L INFO WAS AVAILABLE ON F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTED ATTACHMENT 2.4MM LEGENT, AF02 (B-1) PNEUMATIC SURG DRILL ATTACHMENT LEGEND HBB MEDTRONIC POWERED SURGICAL SOLUTIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1