BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1051483 · Received May 21, 2008

    Report

    Report Number
    1625507-2008-00035
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Report Date
    April 22, 2008
    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 CONFIRMED. EVALUATION OF THE DEVICE NOTED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PT IMPACT. OUR RECOMMENDATION FOR FACTORY SERVICE IS BASED ON THE FACILITY'S USAGE; HOWEVER, IT SHOULD NOT EXCEED 24 MONTHS. THIS DEVICE HAS BEEN IN USE FOR 41 MONTHS WITHOUT ANY RECORD OF FACTORY SERVICE. 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 ROOM STAFF."

    Description of Event or Problem · 1

    REPAIR REQUEST INITIATED FOR DEVICE WITH A REPORT OF A BENT FOOT. NO PT IMPACT REPORTED. REPORT ESCALATED TO COMPLAINT ON EVALUATION DUE TO DAMAGE TO THE FOOTED PORTION OF THE ATTACHMENT. ON FOLLOW-UP, 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