BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT, AF02

    MDR report key: 1334608 · Received March 4, 2009

    Report

    Report Number
    1625507-2009-00016
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Report Date
    February 3, 2009
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT 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 OR STAFF."

    Description of Event or Problem · 1

    DEVICE RETURNED FOR NON-SPECIFIED REPAIR. NO PT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO COMPLAINT ON EVALUATION DUE TO THE FOOTED PORTION BEING DAMAGED BY TOOL CONTACT. ON F/U IT WAS NOTED THAT THIS WAS IDENTIFIED DURING A PROCEDURE AND 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