BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPILOT INFRARED TRANSMITTER

    MDR report key: 2171404 · Received March 5, 2007

    Report

    Report Number
    3005673311-2007-00008
    Event Type
    Injury
    Date Received
    March 5, 2007
    Date of Event
    February 5, 2007
    Report Date
    March 5, 2007
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND ALL AVAILABLE INFORMATION HAS BEEN FORWARDED FOR ANALYSIS TO THE MANUFACTURER, (B)(4). OUR SALES REPRESENTATIVE, INTERVIEWED STERILE PROCESSING DEPARTMENT PERSONNEL TO OBSERVE HOW THE TRANSMITTERS WERE BEING CLEANED. IT WAS DETERMINED THAT THE FACILITY PROCESSES THE FS601 THROUGH THE WASHER WITH THE OTHER INSTRUMENTS AND THEN THEY COME OUT AND DRY AND THEN THEY GO THROUGH 270 DEGREES FOR 4 MINUTES TWICE. AS PER THE INSTRUCTIONS FOR USE: (B)(4) / AESCULAP ORTHOPAEDICS / ORTHOPILOT, THE FS601 ARE TO BE MANUALLY CLEANED. ADDITIONAL SERIAL NUMBER: (B)(4).

    Description of Event or Problem · 1

    A TOTAL KNEE REPLACEMENT WAS CANCELLED AFTER THE PATIENT WAS UNDER ANESTHESIA. THE PATIENT WAS PUT UNDER ANESTHESIA, ORTHOPILOT WAS BROUGHT INTO THE ROOM AND ACTIVE TRANSMITTERS PUT INTO PARTS; 2 SETS OF TRACKERS WERE TRIED. BOTH TIBIAL TRACKERS ((B)(4)) IN BOTH SETS DID NOT FUNCTION. CASE WAS CANCELLED. SURGEON DID NOT WANT TO GO PASSIVE AND PATIENT DID NOT WANT MANUAL SCARSIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPILOT INFRARED TRANSMITTER IMAGE GUIDED SYSTEMS HAW AESCULAP IMPLANT SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK