BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1140555 · Received August 28, 2008

    Report

    Report Number
    1625507-2008-00057
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Report Date
    July 30, 2008
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMENTS: REPORT CONFIRMED ON EVALUATION. THE FOOTED PORTION WAS CUT BY TOOL CONTACT AND DETACHED. ON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. THE PREVENTATIVE MAINTENANCE/SERVICE MANUAL FOR THE LEGEND SYSTEM SPECIFIES SERVICE INTERVALS FOR DEVICES BASED ON THE HOSPITAL USAGE LEVEL. THE MAXIMUM SPECIFIED SERVICE INTERVAL IS 24 MONTHS. DEVICE HAS BEEN IN USE FOR APPROXIMATELY 36 MONTHS WITH NO RECORD OF FACTORY SERVICE DURING THIS PERIOD. 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 PATIENT, 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 PATIENT IMPACT WAS REPORTED. REPORT ESCALATED TO COMPLAINT ON EVALUATION DUE TO THE ATTACHMENT'S FOOT BEING CUT AND DETACHED. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT 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 N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1