BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IB KIT, BC, W/ CC FT AND JUMPSTART

    MDR report key: 19987700 · Received August 14, 2024

    Report

    Report Number
    1220246-2024-07172
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 26, 2024
    Report Date
    September 26, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867318137
    PMA / PMN Number
    K101823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 3.4MM CANNULATED DRILL BIT THAT IS A COMPONENT OF AN AR-1788J-CP INTERNALBRACE¿ IMPLANT SYSTEM, LIGAMENT AUGMENTATION REPAIR, BIOCOMPOSITE, WITH JUMPSTART® DRESSING LOT NUMBER: 15217393 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE TIP OF THE DEVICE WAS BROKEN AND A FRAGMENT WAS MISSING. DIMENSIONAL TESTING WAS PERFORMED USING A CALIPER ID: 1003729. THE LENGTH OF THE DEVICE WAS MEASURED AND FOUND TO BE 4.410, INDICATING THAT THE MISSING FRAGMENT IS AROUND .09, AS THE LENGTH DIMENSION SPECIFIED IN DRAWING C16909 REV 6 IS 4.500. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO MISALIGNED INSERTION AND/OR PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    ON 07/31/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8978-CP DRILL BIT BROKE OFF IN THE BONE, THE FRAGMENT WAS UNABLE TO BE REMOVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY IN CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163193 IB KIT, BC, W/ CC FT AND JUMPSTART BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. IB KIT, BC, W/ CC FT AND JUMPSTART 15217393 00888867318137

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown