BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1317073 · Received January 9, 2009

    Report

    Report Number
    1625507-2009-00002
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Report Date
    December 12, 2008
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMMENTS: REPORT CONFIRMED ON EVAL. THE FOOTED PORTION WAS CUT AND DETACHED. NO ADD'L INFO WAS AVAILABLE ON F/U. OUR RECOMMENDATION FOR FACTORY SERVICE IS BASED ON THE FACILITY'S USAGE, HOWEVER, IT SHOULD NOT EXCEED 24 MONTHS. THIS DEVICE HAS BEEN IN USE FOR 30 MONTHS WITHOUT ANY RECORD OF FACTORY SERVICE. THE USER MANUAL CONTAINS THE FOLLOWING WARNING "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 A CUT FOOT. NO PT IMPACT 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 LEGEND, AF02 (B-1) PNEUMATIC SURG DRILL ATTACHMENT LEGEND HBB MEDTRONIC POWERED SURGICAL SOLUTIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1