BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA, EGRESS, 3.0MM

    MDR report key: 2619113 · Received June 11, 2012

    Report

    Report Number
    1418479-2012-00004
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    April 30, 2012
    Report Date
    May 18, 2012
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY SUBMITTED A PHOTO OF THE BROKEN DEVICE FOR EVALUATION. A FULL INVESTIGATION COULD NOT BE COMPLETED AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE RICHARD WOLF FACILITY AS OF 06/08/2012. DISTRIBUTION DATE: 12/2011. IT APPEARS THE AXIAL FORCE WAS GREATER THAN THE CANNULA COULD WITH STAND RESULTING IN THE TIP BREAKING, OVER 50 LB/F (FOOT POUNDS). ROOT CAUSE OF BREAKAGE IS EXCESSIVE FORCE. RWMIC HAS FOUR MDR'S ON FILE THAT WERE A RESULT OF BREAKAGE DURING A KNEE PROCEDURE (1418479-09-00014, 1418479-09-00016, 1418479-10-00012 AND 1418479-10-00022). A CAPA WAS INITIATED, 10/2009, WHEN THE SECOND MDR WAS RECEIVED. AS A RESULT, WE REVISED OUR INSTRUCTIONS FOR USE ON 06/2010. INTENDED USE SECTION WAS UPDATED AND ADDITIONAL CAUTIONS ADDED REGARDING LIMITED STRENGTH OF DEVICE AND EXCESSIVE FORCE MAY LEAD TO BREAKAGE. THIS IS THE FIRST 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: PATIENT UNDERWENT ACL RECONSTRUCTIVE SURGERY AND WAS SENT HOME. NEXT DAY PATIENT WENT TO EMERGENCY ROOM FOR PAIN, NAUSEA AND VOMITING. TWO DAYS POST PROCEDURE, WHILE CLEANING INSTRUMENTS, TECHNICIAN FOUND VERSE NEEDLE WITH MISSING TIP. PATIENT'S KNEE WAS X-RAYED AND TIP OF NEEDLE WAS LOCATED. PATIENT REQUIRED SECOND SURGERY TO REMOVE FOREIGN BODY. FACILITY INDICATED NO FURTHER PROBLEMS REPORTED AFTER FOREIGN BODY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULA, EGRESS, 3.0MM CANNULA HRX RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8302.09 249S11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other