BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSCLIP/MOTOCLIP SUPERELASTIC FIXATION SYSTEM

    MDR report key: 6591079 · Received May 25, 2017

    Report

    Report Number
    3011421599-2017-00004
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    April 28, 2017
    Report Date
    May 24, 2017
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS, LLC
    Product Code
    JDR
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT TIME OF ORIGINAL SURGERY, SURGEON IMPLANTED 7 CLIPS, 2 PLATES AND 1 SCREW. AT TIME OF REVISION SURGERY, 4 CLIPS WERE FOUND BROKEN. DEVICES WERE NOT RETURNED SO THEREFORE WE ARE UNABLE TO PROPERLY IDENTIFY THE SIZE AND LOT NUMBER OF THE FAILED COMPONENTS. BASED ON XRAYS, WE HAVE DETERMINED ONE 18MM X 14MM X 14MM CLIP WAS BROKE AND 3 20MM X 20MM X 20MM CLIPS WERE BROKE. THERE WERE NO BROKEN PLATES OR SCREWS. PER OUR INVESTIGATION, WE BELIEVE THE HARDWARE FAILURE IS DUE TO PATIENT CONDITIONS AND USE OF PRODUCT IN A CONTRAINDICATED CONDITION. FAILURE OF HARDWARE IS NOT UNEXPECTED IN THESE SORT OF SITUATIONS. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ORIGINAL SURGERY DATE WAS (B)(6) 2016. REVISION SURGERY PERFORMED ON (B)(6) 2017 DUE TO COLLAPSED FOOT AND BROKEN HARDWARE/CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371109 CROSSCLIP/MOTOCLIP SUPERELASTIC FIXATION SYSTEM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE BONE STAPLE JDR CROSSROADS EXTREMITY SYSTEMS, LLC 1402-1814

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention