BEUDAMED
    FDA Adverse Event Other Summary report: N

    APERFIX FEMORAL IMPLANT WITH INSERTER

    MDR report key: 3221816 · Received July 9, 2013

    Report

    Report Number
    3006108336-2013-00006
    Event Type
    Other
    Date Received
    July 9, 2013
    Date of Event
    June 21, 2013
    Report Date
    July 5, 2013
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    HWC
    PMA / PMN Number
    K083612
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED BY CAYENNE MEDICAL. BY THE CONDITION OF THE INSERTER, IT IS EVIDENT THAT EXCESSIVE FORCE FROM A MALLET WAS USED TO INSERT THE IMPLANT INTO POSITION, AND THAT THE SURGEON INSERTED AND MALLETED THE IMPLANT OFF-AXIS TO THE DRILLED TUNNELS. THE PURPLE RELEASE KNOB WAS MISSING, THE FACE PLATE FOR THE WHITE KNOB WAS CRACKED, AND THE IMPLANT SCREW HEAD WAS STILL ATTACHED TO THE INSERTER. THE INTRAOPERATIVE X-RAY THAT WAS PROVIDED SUGGESTS THAT THE INSERTION WAS DONE OFF-AXIS TO THE DRILL TUNNELS, AS THE IMPLANT'S CENTRAL SCREW WAS BENT IN HALF. THE PURPLE PULL KNOB (RELEASES IMPLANT FROM INSERTER AFTER DEPLOYMENT) WAS BROKEN OFF DURING THE ATTEMPTED INSERTION, AND AS A RESULT, THERE WAS NO WAY TO RELEASE THE INSERTER FROM THE IMPLANT. IT APPEARS THAT THE SURGEON TWISTED THE INSERTER AND USED A MALLET TO DETACH THE INSERTER FROM THE IMPLANT, RESULTING IN THE IMPLANT'S SCREW HEAD BEING DETACHED AND REMAINING ON THE INSERTER. THIS INCIDENT OCCURRED DUE TO MISUSE OF THE PRODUCT BY THE SURGEON. THIS INCIDENT OCCURRED BY MISUSE OF THE PRODUCT BY THE SURGEON. COMPLAINT (B)(4) WAS OPENED TO INVESTIGATE THE INCIDENT.

    Description of Event or Problem · 1

    AN APERFIX FEMORAL IMPLANT WAS DEPLOYED BY A SURGEON. IT WAS REPORTED THAT THE DEPLOYED FEMORAL IMPLANT CAME OUT OF THE TUNNEL WHEN PULLING ON THE TIBIAL SIDE DURING SURGERY. SOME BROKEN IMPLANT PIECES REMAINED INSIDE THE PATIENT'S KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314003 APERFIX FEMORAL IMPLANT WITH INSERTER BONE SCREW HWC CAYENNE MEDICAL, INC. CM-2910 40716-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention