BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7X72MM CLEAR TRAC THREADED CANNULA

    MDR report key: 1301320 · Received January 30, 2009

    Report

    Report Number
    1219602-2009-00018
    Event Type
    Malfunction
    Date Received
    January 30, 2009
    Report Date
    December 4, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHICH LOT NUMBER IS ASSOCIATED WITH THIS INCIDENT. THE LOT NUMBERS GIVEN ARE 07091405, 08021405, 08017105, 08070705, AND 08052705. THE USED CANNULA THAT WAS RETURNED WAS EXAMINED AND THERE WAS A SMALL AMOUNT OF MATERIAL MISSING FROM THE DISTAL END.

    Description of Event or Problem · 1

    DURING AN ARTHROSCOPIC SHOULDER SURGERY, SMALL FRAGMENTS WERE MISSING FROM THE DISTAL END OF THE CANNULA BODY. THE SURGEON FELT THAT DUE TO IRRIGATION ALL THE PIECES HAD BEEN REMOVED. DURING A FOLLOW-UP, IT WAS DISCOVERED THAT THERE WERE TWO PROCEDURES IN WHICH THE CANNULA WAS USED THAT REQUIRED A RETURN TO THE THEATER DUE TO THE PRESENCE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7X72MM CLEAR TRAC THREADED CANNULA 7X72MM CLEAR TRAC THREADED CANNULA HRX SMITH & NEPHEW INC., ENDOSCOPY DIVISION 72200905

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention