BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOCLIP SUPERELASTIC FUSION SYSTEM

    MDR report key: 8465669 · Received March 29, 2019

    Report

    Report Number
    3011421599-2017-00008
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    October 25, 2017
    Report Date
    November 17, 2017
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS LLC
    Product Code
    JDR
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE BASED ON THE INFORMATION AVAILABLE AND THE EVALUATION OF THE X-RAY. PART#/LOT# OF FRACTURED STAPLE IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT FOLLOWED THE SURGEON'S INSTRUCTIONS FOR WEIGHT BEARING. THERE ARE MULTIPLE LOTS OF CLIPS WHICH WERE INVOLVED IN THIS CASE. IT IS UNKNOWN WHICH LOT OF CLIP EXPERIENCED MECHANICAL FAILURE. IT ALSO APPEARS AS IF THERE IS POSSIBLE MECHANICAL FAILURE OF THE PLATE AND A SCREW. ALL PART AND LOT NUMBER INFORMATION FOR ALL THE IMPLANTS INVOLVED WILL BE POSTED BELOW. P/N: 1418-2222, LOT: 101497, UDI: (B)(4), EXPIRATION DATE: 07/08/2018, DESCRIPTION: MOTOCLIP IMPLANT KIT 18MM X 22MM X 22MM. P/N: 1418-2222, LOT: 101956, UDI: (B)(4), EXPIRATION DATE: 01/23/2019, DESCRIPTION: MOTOCLIP IMPLANT KIT 18MM X 22MM X 22MM. P/N: 1418-1818, LOT: 101854, UDI: (B)(4), EXPIRATION DATE: 12/16/2018, DESCRIPTION: MOTOCLIP IMPLANT KIT 18MM X 18MM X 18MM. P/N: 7100-RD18, LOT: 102026, UDI: (B)(4) EXPIRATION DATE: N/A, DESCRIPTION: DYNAFORCE VERO PLATE DISTAL PLATE 18MM. P/N: 1500-3022, LOT: 101428, UDI: (B)(4), EXPIRATION DATE: 05/01/2021, DESCRIPTION: MOTOBAND CP LOCKING SCREW 3.0MM X 22MM. P/N: 1500-3024, LOT: 101429, UDI: (B)(4), EXPIRATION DATE: 04/01/2021, DESCRIPTION: MOTOBAND CP LOCKING SCREW 3.0MM X 24MM.

    Description of Event or Problem · 1

    ORIGINAL DATE OF SURGERY - (B)(6) 2017. FAILURE DETECTION DATE - 10/25/2017. POST-OPERATIVE FOLLOW UP VISIT DISCOVERED ONE NITIONOL STAPLE FRACTURE PER SURGEON, PATIENT HAS FUSED AND IS NOT EXPERIENCING ANY PAIN OR DISCOMFORT FROM MECHANICAL FAILURE. REVISION SURGERY NOT SCHEDULED NOR EXPECTED. PATIENT INITIALLY UNDERWENT SURGERY TO CORRECT A CHARCOT FOOT. PATIENT'S CONTRALATERAL LEG WAS AMPUTATED AT THE HIP AT AN EARLY AGE. THIS LIKELY LED TO PATIENT BEARING WEIGHT EARLIER THAN RECOMMENDED AND RESULTED IN THE MECHANICAL FAILURE OF THE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257079 MOTOCLIP SUPERELASTIC FUSION SYSTEM SINGLE/MULTIPLE COMPONENT BONE FIXATION APPLIANCE, BONE STAPLE JDR CROSSROADS EXTREMITY SYSTEMS LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR