BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-COMP-SITE P-LCK 2.9X15.5MM

    MDR report key: 14603027 · Received June 6, 2022

    Report

    Report Number
    1220246-2022-05030
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    April 18, 2022
    Report Date
    June 6, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867023017
    PMA / PMN Number
    K101679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 5/19/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1923BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE DURING INSERTION. SURGEON REMOVED ALL BROKEN FRAGMENTS FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365911 BIO-COMP-SITE P-LCK 2.9X15.5MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. BIO-COMP-SITE P-LCK 2.9X15.5MM 14477935 00888867023017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown