BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTECH GPS SYSTEM

    MDR report key: 5401305 · Received February 1, 2016

    Report

    Report Number
    3008027912-2016-00006
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Date of Event
    November 17, 2014
    Report Date
    August 16, 2016
    Manufacturer
    BLUE ORTHO
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING SURGICAL CASE USING THE EXACTECH GPS SYSTEM, (B)(4) (IMPORTER OF THE DEVICE) REPORTED TO BLUE ORTHO (MANUFACTURER OF THE DEVICE) THAT THE DISTAL FEMUR CUT SEEMED TO BE OFF. THIS SITUATION HAS REPORTEDLY BEEN HAPPENING FOLLOWING A SOFTWARE UPGRADE.

    Description of Event or Problem · 1

    DURING SURGICAL CASE USING THE (B)(4) GPS SYSTEM, (B)(4) (IMPORTER OF THE DEVICE) REPORTED TO BLUE ORTHO (MANUFACTURER OF THE DEVICE) THAT THE DISTAL FEMUR CUT SEEMED TO BE OFF. THIS SITUATION HAS REPORTEDLY BEEN HAPPENING FOLLOWING A SOFTWARE UPGRADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59945 EXACTECH GPS SYSTEM BLUE NAVIGATION SYSTEM OLO BLUE ORTHO GPS TRACKER G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other