BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA, EGRESS, 3.0MM

    MDR report key: 2937044 · Received January 4, 2013

    Report

    Report Number
    1418479-2012-00011
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    October 22, 2012
    Report Date
    December 7, 2012
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL INVESTIGATION COULD NOT BE COMPLETED AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE RICHARD WOLF FACILITY AS OF (B)(4) 2013. IF EXCESSIVE AXIAL FORCE IS APPLIED, GREATER THAN 50LB/F (FOOT POUNDS), THE CANNULA TIP WILL BREAK. RWMIC HAS FIVE MDR'S ON FILE THAT WERE A RESULT OF BREAKAGE DURING A KNEE PROCEDURE: (1418479-09-00014, 1418479-09-00016, 1418479-10-00012, 1418479-10-00022, 1418479-2012-00004) A CAPA WAS INITIATED, 10/2009, WHEN THE SECOND MDR WAS RECEIVED. AS A RESULT, WE REVISED OUR INSTRUCTIONS FOR USE ON 06/10. INTENDED USE SECTION WAS UPDATED AND ADDITIONAL CAUTIONS ADDED REGARDING LIMITED STRENGTH OF DEVICE AND EXCESSIVE FORCE MAY LEAD TO BREAKAGE. THIS IS THE SECOND EVENT SINCE THE UPDATE HAS BEEN AVAILABLE FOR NEW DEVICE PURCHASES. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. I.E. INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. RICHARD WOLF CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    FACILITY HAS REPORTED THE FOLLOWING: PROCEDURE: ACL RECONSTRUCTIVE ARTHROSCOPIC SURGERY. EVENT: DURING THE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, THE METAL TIP OF THE OUTFLOW CANNULA BROKE OFF IN THE PATIENTS JOINT AT THE FENESTRATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5542 CANNULA, EGRESS, 3.0MM CANNULA HRX RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8302.09

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other