BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT

    MDR report key: 1922960 · Received December 13, 2010

    Report

    Report Number
    1625507-2010-00079
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. IT WAS ALSO NOTED THAT THE INTERNAL TUBE BEARINGS HAD FAILED, THE COLOR BAND WAS FADED AND THE ETCHING WAS ILLEGIBLE. 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 35 MONTHS WITHOUT ANY RECORD OF FACTORY SERVICE.

    Description of Event or Problem · 1

    DEVICE RETURNED FOR NON-SPECIFIED REPAIR. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO COMPLAINT ON EVALUATION DUE TO THE ATTACHMENT FOOT BEING DAMAGED BY TOOL CONTACT. ON FOLLOW-UP, IT WAS NOTED THAT NO INTERNAL REPORT WAS FILED AND NO PATIENT DEMOGRAPHIC INFORMATION WAS AVAILABLE. 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