BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1358916 · Received February 17, 2009

    Report

    Report Number
    1625507-2009-00009
    Event Type
    Malfunction
    Date Received
    February 17, 2009
    Report Date
    January 19, 2009
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMMENTS: REPORT CONFIRMED ON EVAL. THE FOOTED PORTION WAS CUT AND DETACHED. ON F/U IT WAS CONFIRMED THAT THERE WAS NO PT IMPACT. 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

    NON-SPECIFIED REPAIR REQUEST INITIATED FOR DEVICE. NO PT IMPACT REPORTED. REPORT ESCALATED TO COMPLAINT ON EVAL, DUE TO THE FOOTED PORTION BEING CUT AND DETACHED. ON F/U IT WAS CONFIRMED THAT THERE WAS NO PT IMPACT.

    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