BEUDAMED
    FDA Adverse Event Other Summary report: N

    APERFIX CORING REAMER REMOVAL TOOL

    MDR report key: 2693584 · Received August 8, 2012

    Report

    Report Number
    3006108336-2012-00002
    Event Type
    Other
    Date Received
    August 8, 2012
    Date of Event
    July 11, 2012
    Report Date
    August 7, 2012
    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. THE SURGEON REMOVED THE BROKEN PIECES AND COMPLETED THE SURGERY.

    Description of Event or Problem · 1

    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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention