BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT

    MDR report key: 3811420 · Received May 15, 2014

    Report

    Report Number
    1625507-2014-00034
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. PREVIOUS INVESTIGATION PERFORMED UNDER (B)(4) DETERMINED THAT THE LIKELY CAUSES ARE DEBRIS IN THE MOTOR COLLET AND IMPROPER INSERTION OF THE TOOL. ADDITIONALLY, THE DISTAL AND INTERNAL TUBE BEARINGS WERE CORRODED; LASER MARKINGS AND COLOR BAND WERE FADED. 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 52 MONTHS WITH NO RECORD OF FACTORY SERVICE DURING THIS PERIOD. WE WILL CONTINUE TO MONITOR THIS COMPLAINT TYPE FOR TRENDS.

    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 PHYSICAL DAMAGED FOUND OF ATTACHMENT FOOT BEING DAMAGED BY TOOL CONTACT. ON FOLLOW UP, IT WAS REPORTED THAT THE MALFUNCTION WAS IDENTIFIED DURING CLEANING FROM A CRANIOTOMY CASE. IT WAS CONFIRMED THERE WAS NO PATIENT IMPACT, DELAYS OR ISSUES. INITIAL REPORTER WAS ALSO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290024 LEGEND FOOTED ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1