BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT, AF02

    MDR report key: 1493752 · Received August 7, 2009

    Report

    Report Number
    1625507-2009-00052
    Event Type
    Malfunction
    Date Received
    August 7, 2009
    Date of Event
    June 1, 2009
    Report Date
    July 9, 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

    REPORT CONFIRMED. EVAL DETERMINED THAT THE ATTACHMENT WAS DAMAGED BY TOOL CONTACT. NO ADD'L INFO WAS AVAILABLE ON F/U. EVENT DATE ESTIMATED. 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 DISSECTION TOOL MAY CAUSE INJURY TO THE PT, OPERATOR AND/OR OPERATING ROOM STAFF."

    Description of Event or Problem · 1

    DEVICE RETURNED FOR NON-SPECIFIED REPAIR. NO PT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO COMPLAINT ON EVAL DUE TO ATTACHMENT BEING DAMAGED BY TOOL CONTACT. NO ADD'L INFO WAS AVAILABLE ON F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND FOOTED ATTACHMENT, AF02 HBB - MOTOR, DRILL, PNEUMATIC HBB MEDTRONIC POWERED SURGICAL SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1