BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT

    MDR report key: 2840653 · Received November 20, 2012

    Report

    Report Number
    1625507-2012-00111
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. A PORTION OF THE FOOT OF THE ATTACHMENT WAS DETACHED AND MISSING. (B)(4) WAS INITIATED TO INVESTIGATE THIS MALFUNCTION. 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." WE WILL CONTINUE TO MONITOR THIS COMPLAINT TYPE FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    DEVICE RETURNED FOR REPAIR WITH REPORTED MALFUNCTION OF ATTACHMENT FOOT BENT. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO COMPLAINT ON EVALUATION DUE TO ATTACHMENT FOOT WAS FOUND DAMAGED BY TOOL CONTACT. ON FOLLOW UP IT WAS REPORTED THAT THE MALFUNCTION WAS IDENTIFIED DURING A CRANIOTOMY SURGERY. PROCEDURE WAS COMPLETED WITH BACK UP. IT WAS CONFIRMED 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