BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR-TRAC COMPLETE 5.5MM X 72MM

    MDR report key: 759930 · Received August 2, 2006

    Report

    Report Number
    1219602-2006-00106
    Event Type
    Malfunction
    Date Received
    August 2, 2006
    Date of Event
    March 20, 2006
    Report Date
    August 2, 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

    NO PRODUCT WAS RETURNED FOR EVALUATION THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED DEVICE FAILURE.

    Description of Event or Problem · 1

    SMITH & NEPHEW REPORTED THE 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. THE ARTHROSCOPIC BANKART REPAIR WAS DELAYED 30-MINUTES AS A RESULT. THE SURGEON WAS NOT ABLE TO FIND THE MISSING PIECES IN THE PATIENT. HE FEELS THAT IT MAY HAVE DROPPED ONTO THE FLOOR WHEN RETRIEVING THE CANNULA FROM THE PT'S BODY. THE PT DID NOT HAVE ANY ADVERSE REACTIONS NOR DID HE HAVE TO HAVE A 2ND SURGERY TO REMOVE FOREIGN BODY AND THE PT IS WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other