BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND FOOTED ATTACHMENT

    MDR report key: 3803026 · Received May 9, 2014

    Report

    Report Number
    1625507-2014-00032
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    REPORT INCONCLUSIVE. NO EVALUATION COULD BE PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE EXTENT OF THE DAMAGE TO THE ATTACHMENT. 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 45 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

    IT WAS REPORTED THAT "ABOUT THREE WEEKS AFTER THE SURGERY, IT WAS DISCOVERED THAT A TIP OF THE PLATE BROKE OFF IN THE PATIENT¿S HEAD. THEY DECIDED TO LEAVE IT IN BECAUSE IT IS TOO MUCH OF A RISK TO PUT THE PATIENT UNDER ANESTHESIA TO REMOVE IT."THE SURGEON'S NAME AND CONTACT FACILITY PERSONNEL WERE ALSO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281977 LEGEND FOOTED ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1