BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3040334 · Received January 17, 2008

    Report

    Report Number
    1625507-2008-00002
    Event Type
    Malfunction
    Date Received
    January 17, 2008
    Report Date
    December 15, 2007
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: REPORT WAS CONFIRMED BY EVALUATION. THE FOOTED PORTION OF THE ATTACHMENT CUT BY TOOL CONTACT. THE USER MANUAL STATES "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 ROOT STAFF."

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR REPAIR BY THE USER FACILITY AND ESCALATED TO A COMPLAINT DUE TO THE FOOTED PORTION OF THE ATTACHMENT CUT BY TOOL CONTACT. ON FOLLOW-UP IT WAS NOTED THAT THIS WAS IDENTIFIED AFTER THE SURGEON TURNED THE FLAP DURING A CRANIOTOMY PROCEDURE. 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