BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTOCLIP 15MM SUPER ELASTIC IMPLANT KIT

    MDR report key: 6070286 · Received November 1, 2016

    Report

    Report Number
    3011421599-2016-00002
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 7, 2016
    Report Date
    November 1, 2016
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    UDI-DI
    00850310006090
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A 15MM MOTOCLIP WAS USED TO FIXATE AN AUSTIN BUNIONECTOMY. ONE LEG OF THE MOTOCLIP WAS ALLEGEDLY CUT TO SHORTEN THE LENGTH OF THE LEG. UPON INSERTION OF THE CLIP, SUPPOSEDLY THE LEGS DID NOT APPEAR TO LINE UP CORRECTLY WITH THE PRE DRILLED HOLES IN THE BONE. A MALLET WAS USED TO FULLY INSERT THE CLIP INTO THE PREPARED HOLES. UPON REMOVAL OF THE INSERTER, IT WAS NOTICED THAT THE BONE CORTEX WAS CRACKED DORSALLY. NO X-RAYS HAVE BEEN PROVIDED. A K-WIRE(S) WAS USED TO ADDRESS THE CRACKED CORTEX..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720511 MOTOCLIP 15MM SUPER ELASTIC IMPLANT KIT STAPLE, FIXATION, BONE JDR CROSSROADS EXTREMITY SYSTEMS 1442-1515 101154 00850310006090

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention