BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR-TRAC COMPLETE 5.5MM X 72MM

    MDR report key: 773688 · Received August 10, 2006

    Report

    Report Number
    1219602-2006-00115
    Event Type
    Malfunction
    Date Received
    August 10, 2006
    Date of Event
    March 20, 2006
    Report Date
    August 10, 2006
    Manufacturer
    SMITH & NEPHEW, INC., ENDOSCOPY DIVISION
    Product Code
    NBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE SHOWED THE DISTAL END OF THE CANNULA IS BROKEN AND SMALL PIECES ARE MISSING. CONDITION OF THE DEVICE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED HOWEVER, A CONCLUSION COULD NOT BE MADE FOR THE REPORTED FAILURE.

    Description of Event or Problem · 1

    A PIECE DID BREAK OFF INSIDE BODY OF PT AND THEY WERE ABLE TO REMOVE MOST OF IT. SURGEON INTRODUCED THE DISPOSABLE CANNULA, PUSHING THE CANNULA INTO THE SHOULDER JOINT. WHEN THE CANNULA WAS IN PLACE, HE REMOVED THE GUIDING ROD FROM THE POSTERIOR PORTAL AND RE-INSERTED THE TELESCOPE TO CARRY ON WITH THE PROCEDURE. IT WAS THEN DISCOVERED THAT, THE TIP PORTION OF THE DISPOSABLE WAS BROKEN. A DELAY OF THIRTY MINUTES RESULTED. BACK-UP DEVICES WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR-TRAC COMPLETE 5.5MM X 72MM SEARCH OF RECORDS SHOWS NBL SMITH & NEPHEW, INC., ENDOSCOPY DIVISION 7209987 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other