BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT

    MDR report key: 2180621 · Received July 27, 2011

    Report

    Report Number
    1625507-2011-00099
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. THE USER MANUAL CONTAINS THE FOLLOWING WARNING "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." 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 32 MONTHS WITHOUT ANY RECORD OF FACTORY SERVICE.

    Description of Event or Problem · 1

    DEVICE RETURNED FOR NON-SPECIFIED REPAIR. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO COMPLAINT ON DECONTAMINATION DUE TO THE ATTACHMENT BEING DAMAGED BY TOOL CONTACT. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND FOOTED ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1