BEUDAMED
    FDA Adverse Event Other Summary report: N

    APERFIX CORING REAMER REMOVAL TOOL

    MDR report key: 3199561 · Received June 25, 2013

    Report

    Report Number
    3006108336-2013-00003
    Event Type
    Other
    Date Received
    June 25, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 25, 2013
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE APERFIX CORING REAMER IS INTENDED FOR REMOVAL OF THE CAYENNE MEDICAL APERFIX FEMORAL IMPLANTS IN ACL POST SURGERY REVISION CASES. UPON FURTHER DISCUSSIONS WITH THE SALES REP, IT WAS REPORTED THAT THE CORING REAMER IN THIS INCIDENT WAS USED TO CREATE A TIBIAL TUNNEL FOR DEPLOYMENT OF A TIBIAL IMPLANT, WHICH IS NOT THE INTENDED USE OF THE PRODUCT. IT IS POSSIBLE THAT THE REAMER WAS DAMAGED DUE TO OFF-AXIS DRILLING IN THE TUNNEL AND CONTACT WITH A GUIDE PIN OR THE HIGH BONE DENSITY OF THE TIBIAL CORTEX (AS COMPARED TO THE FEMORAL CONDYLE, THE LOCATION OF THE INTENDED USE) CONTRIBUTED TO THE DEVICE FAILURE. PER AN EMAIL DATED (B)(6) 2013 FROM THE SURGEON, HE LOOKED FOR EVERY PIECE POSSIBLE USING THE ARTHROSCOPE AND FLUOROSCOPY. THE SURGEON NOTED A PIECE WAS IN A VERY POSTERIOR PART OF THE KNEE JOINT THAT WAS VERY DIFFICULT TO REACH DUE TO POTENTIAL INJURY TO NEUROVASCULAR STRUCTURES. THE SURGEON ELECTED TO OBSERVE AND IF THE FRAGMENT MOVED AND/OR THE PT PRESENTED WITH A PROBLEM THAT MIGHT BE RELATED TO THE FRAGMENT, HE WOULD GO FORWARD WITH REMOVAL. AT PT'S LAST VISIT THE SURGEON OBTAIN AN X-RAY WHICH SHOWED THE FRAGMENT HAD MOVED TO THE ANTERIOR KNEE JOINT. ACCORDING TO THE SURGEON THE SWELLING COULD BE A REACTION TO THIS FOREIGN BODY AND COULD BE RESOLVED WITH SCOPE REMOVAL OF THE FRAGMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012 AN APERFIX CORING REAMER IMPLANT REMOVAL TOOL WAS USED NOT AS INTENDED TO CREATE A TIBIAL TUNNEL. THE SURGEON REPORTED THAT THE APERFIX CORING REAMER FRACTURED IN THE PT'S KNEE. THE SURGEON HAD TO REMOVE THE PIECES. THE CORING REAMER WAS RETURNED TO CAYENNE MEDICAL FOR EVAL. THIS ADVERSE EVENT HAD BEEN REPORTED UNDER 3006108336-2012-00002 REPORT TO THE AGENCY. ON (B)(6) 2013 CAYENNE MEDICAL WAS NOTIFIED ABOUT AN ADDITIONAL POTENTIAL ADVERSE EVENT POSSIBLY RELATED TO THE PT. THE PT WENT BACK TO HER SURGEON APPROX 11 MONTHS LATER AND COMPLAINED ABOUT SWELLING IN HER OPERATED KNEE. THE SURGEON TOOK AN X-RAY IMAGE OF THE KNEE AND BELIEVES THE SWELLING COULD BE DUE TO FOREIGN BODY REACTION TO A REMAINING FRAGMENT OF THE FRACTURED CORING REAMER FROM THE PREVIOUS SURGERY/EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289342 APERFIX CORING REAMER REMOVAL TOOL REAMER HTO CAYENNE MEDICAL, INC. CM-7109-ST NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention