BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA, EGRESS, 3.0MM

    MDR report key: 2985988 · Received February 6, 2013

    Report

    Report Number
    1418479-2013-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    November 5, 2012
    Report Date
    January 4, 2013
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    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 501LB/F (FOOT POUNDS), THE CANNULA TIP WILL BREAK. RWMIC HAS SEVEN 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, 1418479-2012-00011) A CAPA WAS INITIATED, (B)(4) 2009, WHEN THE SECOND MDR WAS RECEIVED. AS A RESULT, WE REVISED OUR INSTRUCTIONS FOR USE ON (B)(4). INTENDED USE SECTION WAS UPDATED AND ADD'L CAUTIONS ADDED REGARDING LIMITED STRENGTH OF DEVICE AND EXCESSIVE FORCE MAY LEAD TO BREAKAGE. THIS IS THE FORTH EVENT SINCE THE UPDATE HAS BEEN AVAILABLE FOR NEW DEVICE PURCHASES. TWO OF THE EVENTS OCCURRED WITHIN A TWO MONTH TIME FRAME AT THE SAME FACILITY. DEVICE IS OVER TEN YEARS OLD. 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 ADD'L INFO IS REC'D, WE WILL PROVIDE FDA WITH FOLLOW-UP INFO.

    Description of Event or Problem · 1

    PROCEDURE: ARTHROSCOPY. ARTHROSCOPY WAS PERFORMED ON RIGHT KNEE ON (B)(6) 2012. ARTHROSCOPY REVEALED TORN ANTERIOR HORN OF MEDIAL MENISCUS AND A SIGNIFICANT DEGENERATIVE CHANGES. THE PT HAD GOOD INITIAL RESPONSE. AFTER 8 DAYS PT REPORTED PAIN. COTISONE AND SYNVISC INJECTIONS WERE GIVEN BUT HAD MINIMAL RESPONSE. ON (B)(6) 2012 A REPEAT ARTHROSCOPY WAS PERFORMED ON THE RIGHT KNEE TO REMOVE FOREIGN BODY. IN ADDITION SHAVING OF ARTHRITIC CHANGES, MEDIAL FEMORAL CONDYLE AND PATELLOFEMORAL JOINT WAS PERFORMED. FOREIGN BODY THAT WAS REMOVED WAS IDENTIFIED AS A BROKEN PIECE OF RICHARD WOLF CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49986 CANNULA, EGRESS, 3.0MM CANNULA, 3.0MM HRX RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8302.09 73R00

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention