BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1062062 · Received June 13, 2008

    Report

    Report Number
    1625507-2008-00038
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 16, 2008
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMMENTS: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE DESPITE NUMEROUS ATTEMPTS. THIS EVENT IS BEING REPORTED DUE TO THE INABILITY TO RULE OUT A MALFUNCTION THAT MAY RESULT IN A PATIENT INJURY. 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

    NON-SPECIFIED REPAIR REQUEST INITIATED FOR DEVICE. REPORT ESCALATED TO COMPLAINT DUE TO RETURN WITHIN 90 DAYS OF REPAIR OR SALE. NO PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE ON FOLLOW-UP.

    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