BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19781914 · Received July 19, 2024

    Report

    Report Number
    1220246-2024-06817
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 7, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867023017
    PMA / PMN Number
    K173240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE EYELET AND SCREW ARE MISSING FROM THE DEVICE. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE METHOD OF BONE PREPARATION AND THE QUALITY OF THE BONE ENCOUNTERED WERE NOT PROVIDED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER BONE PREPARATION, MISALIGNED INSERTION AND/OR PRYING/LEVERAGING DURING USE.

    Description of Event or Problem · 0

    ON 25TH JUNE 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1923BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 2.9 X 15.5 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN AN ANTERIOR TALOFIBULAR LIGAMENT REPAIR SURGERY ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1923BC. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552114 BIO-COMP-SITE P-LCK 2.9X15.5MM BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP-SITE P-LCK 2.9X15.5MM 15131362 00888867023017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown