BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA SET, THREADED, 6MM X 75MM

    MDR report key: 1011909 · Received March 10, 2008

    Report

    Report Number
    1017294-2008-00165
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    GEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THE CANNULA FOR EVALUATION. A VISUAL EXAMINATION NOTED THAT A PIECE OF CANNULA BROKE OFF AT THE DISTAL END. A REVIEW OF PRODUCT HISTORY FOUND REPORTS OF THIS FAILURE MODE. A REVIEW OF PRODUCT HISTORY FOUND REPORTS OF THIS FAILURE MODE TO BE LOW, 0.01%. A CORRECTIVE ACTION IS IN PROCESS TO ADDRESS THIS PROBLEM. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS DEVICE FOR FAILURES.

    Description of Event or Problem · 1

    FOLLOWING SURGICAL USE OF THIS CANNULA, THE USER NOTED THAT A PIECE BROKE OFF THE END OF THE DEVICE AND COULD NOT BE FOUND. THE SURGEON WAS NOTIFIED AND RESCRUBED TO SURGICALLY REENTERED THE JOINT. AFTER 20 MINUTES OF SEARCHING, IT WAS DETERMINED THAT THE PIECE OF CANNULA WAS NOT IN THE JOINT. IN ADDITION, THE USER REPORTED THAT THE PIECE OF CANNULA WAS NOT FOUND IN THE OR SUITE. THERE WAS NO KNOWN INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULA SET, THREADED, 6MM X 75MM DISPOSABLE CANNULA GEA CONMED LINVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other