BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1203465 · Received October 17, 2008

    Report

    Report Number
    1625507-2008-00062
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    September 20, 2008
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMMENTS: REPORT WAS CONFIRMED BY EVALUATION. A PORTION OF THE FOOT OF THE ATTACHMENT WAS DETACHED AND MISSING. IT WAS NOTED THAT THE ATTACHMENT FOOT HAD BEEN DAMAGED BY TOOL CONTACT. 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 31 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 PATIENT, OPERATOR AND/OR OPERATING ROOM STAFF."

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR NON-SPECIFIED REPAIR. NO PATIENT IMPACT WAS REPORTED. REPAIR REQUEST WAS ESCALATED TO COMPLAINT DUE TO EVALUATION FINDINGS OF ATTACHMENT FOOT MISSING. NO ADDITIONAL INFORMATION WAS AVAILABLE ON FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTED ATTACHMENT 2.4 MM LEGEND, AF02 (B-1) PNEUMATIC SURG DRILL ATTACHMENT LEGEND HBB MEDTRONIC POWERED SURGICAL SOLUTIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1