BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT, AF02

    MDR report key: 1473995 · Received August 14, 2009

    Report

    Report Number
    1625507-2009-00055
    Event Type
    Malfunction
    Date Received
    August 14, 2009
    Date of Event
    July 17, 2009
    Report Date
    July 17, 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 FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. 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

    DURING AN ANEURYSM PROCEDURE THE FOOT OF THE AF02 BROKE OFF AND WAS NOT RETRIEVED FROM THE PT'S WOUND SITE. NO PT IMPACT WAS REPORTED. ON F/U IT WAS CONFIRMED THAT THERE WAS NO PT IMPACT.

    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