BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT

    MDR report key: 3955038 · Received July 24, 2014

    Report

    Report Number
    1625507-2014-00042
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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. IT WAS ALSO NOTED THAT THE INTERNAL TUBE BEARING WAS CORRODED; COLOR BAND AND MARKINGS WERE FADED. PREVIOUS INVESTIGATION PERFORMED UNDER (B)(4) DETERMINED THAT THE LIKELY CAUSES ARE DEBRIS IN THE MOTOR COLLET AND IMPROPER INSERTION OF THE TOOL. THE USER MANUAL CONTAINS THE FOLLOWING WARNING ¿DO NOT USE A LEGEND ATTACHMENT IF ANY PART OF THE ATTACHMENT APPEARS TO BE BENT, LOOSE, MISSING, OR DAMAGED.¿ ADDITIONAL WARNING INDICATES ¿DO NOT USE EXCESSIVE PRESSURE, SUCH AS BENDING OR PRYING, ON ATTACHMENTS OR DISSECTING TOOLS. THIS MAY CAUSE TOOL TO BEND OR BREAK AND CAUSE INJURY TO PATIENT, OPERATOR AND/OR OPERATING ROOM STAFF.¿IN ADDITION, ¿A TACTILE AND AUDIBLE CLICK WILL BE OBSERVED WHEN ATTACHMENT IS FULLY SEATED. TACTILE FEEDBACK IS FELT WHEN THE DISSECTING TOOL IS FULLY SEATED. TURN THE TOOL LOCKING RING TO THE ¿LOCK¿ POSITION. VERIFY THAT THE TOOL IS IN PLACE BY GENTLY PULLING ON THE TOOL.¿ THE PREVENTIVE MAINTENANCE/SERVICE MANUAL FOR THE LEGEND SYSTEM SPECIFIES SERVICE INTERVALS FOR DEVICES BASED ON THE HOSPITAL USAGE LEVEL. THE MAXIMUM SPECIFIED SERVICE INTERVAL IS 24 MONTHS. DEVICE HAS BEEN IN USE FOR APPROXIMATELY 36 MONTHS WITH NO RECORD OF FACTORY SERVICE DURING THIS PERIOD. WE WILL CONTINUE TO MONITOR THIS COMPLAINT TYPE FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    DEVICE RETURNED FOR NON-SPECIFIED REPAIR. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO COMPLAINT ON EVALUATION DUE TO ATTACHMENT FOOT BEING DAMAGED BY TOOL CONTACT. ON FOLLOW UP IT WAS REPORTED THAT THE MALFUNCTION WAS IDENTIFIED DURING CLEANING IN (B)(6) 2014. IT WAS CONFIRMED THERE WAS NO PATIENT OR STAFF IMPACT. INITIAL REPORTER WAS ALSO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434450 LEGEND FOOTED ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1