BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1071712 · Received July 9, 2008

    Report

    Report Number
    1625507-2008-00044
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Report Date
    June 13, 2008
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMENTS: REPORT CONFIRMED ON EVAL. ON FOLLOW-UP IT WAS NOTED THAT THIS WAS IDENTIFIED DURING SURGERY AND 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 27 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

    NON-SPECIFIED REPAIR REQUEST INITIATED FOR DEVICE. NO PT IMPACT WAS REPORTED. REPORT ESCALATED TO COMPLAINT ON EVAL DUE TO THE FOOTED PORTION BEING DETACHED AND MISSING. ON FOLLOW-UP IT WAS NOTED THAT THIS WAS IDENTIFIED DURING SURGERY AND 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