BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOCLIP

    MDR report key: 15501764 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00018
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    May 17, 2017
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    UDI-DI
    00850310006083
    PMA / PMN Number
    K181410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LHR WAS REVIEWED FOR THE KIT (P/N 1442-1010 LOT 101500) AND THE PICK LIST REVEALED THE FOLLOWING LOTS WERE USED FOR EACH OF THE PARTS. IMPLANT (P/N 1402-1010 LOT 101222). INSERTER (P/N 100024 LOT 101278). LOADING BLOCK (P/N 220070 LOT 101287). ALL OF THE PREVIOUSLY MENTIONED LHRS WERE REVIEWED AND NO EVIDENCE WAS FOUND TO SUGGEST THAT ANY OF THE PARTS DID NOT MEET SPECIFICATIONS PRIOR TO DISTRIBUTION. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT AN INEXPERIENCED WHO IS UNFAMILIAR WITH LOADING THE IMPLANT ONTO THE INSERTER IS MORE LIKELY TO EXPERIENCE THIS FAILURE MODE.

    Description of Event or Problem · 0

    WHILE THE NURSE WAS ATTEMPTING TO LOAD THE IMPLANT ONTO THE INSERTER SHE HAD DIFFICULTY DOING SO AND THE REP FELT AS IF THE LEGS OF THE INSERTER MIGHT HAVE BEEN BENT OR WEAKENED IN THE PROCESS. AFTER MENTIONING THIS TO THE DOCTOR, THE DOCTOR TESTED THE LEGS OF THE INSERTER WHILE THE IMPLANT WAS LOADED AND ONE LEG OF THE INSERTER IMMEDIATELY BROKE WITH EASE. THE BROKEN PIECES WERE DISCARDED AND ANOTHER KIT WAS OPENED AND SUCCESSFULLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2928945 MOTOCLIP STAPLE, FIXATION, BONE JDR CROSSROADS EXTREMITY SYSTEMS 1442-1010 101500 00850310006083

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other