BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23547087 · Received November 13, 2025

    Report

    Report Number
    1220246-2025-05069
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867023017
    PMA / PMN Number
    K173240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT REGARDING ANCHOR BREAKAGE IS CONFIRMED BASED ON FIELD IMAGES SHOWING FRACTURED COMPONENT FRAGMENTS. AFTER REVIEWING ALL AVAILABLE INFORMATION ¿ INCLUDING THE RETURNED DEVICE (IF APPLICABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST PROBABLE CAUSE. THE LIKELY CAUSE IS A USER ERROR, ATTRIBUTED EITHER TO MISALIGNED INSERTION OR PRYING/LEVERAGING OF THE SCREW DURING PLACEMENT. THE ALLEGATION CONCERNING MISSING TRACTION TOWER COMPONENTS CANNOT BE CONFIRMED, AS NO SUPPORTING PHOTOGRAPHIC EVIDENCE WAS PROVIDED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN ANCHOR BREAKAGE OCCURRED DURING THE REPAIR PROCEDURE INVOLVING AR-1923BC BIOCOMPOSITE PUSHLOCK SUTURE ANCHORS (2.9 X 15.5 MM). UPON ARRIVAL AT THE FACILITY, IT WAS NOTED THAT ITEMS WERE MISSING IN THE SURGICAL KIT, SPECIFICALLY COMPONENTS REQUIRED FOR THE TRACTION TOWER. ONCE THE ISSUE WAS RESOLVED AND THE SURGERY COMMENCED, THE REPORTING TECHNICIAN ASSISTED WITH INSTRUMENTING THE PROCEDURE. THE PERFORATIONS WERE PERFORMED BY A MEDICAL RESIDENT, WHILE THE SURGEON INSERTED THE ANCHORS. THE FIRST ANCHOR BROKE DUE TO INCORRECT ALIGNMENT DURING INSERTION. A SECOND ANCHOR WAS PLACED CORRECTLY AND REMAINED INTACT. DESPITE CONFIRMING THE MATERIAL WAS APPROPRIATE FOR USE, SUBSEQUENT ANCHORS CONTINUED TO BREAK DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER PRODUCT. THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY FOR BANKART AND HILL-SACHS LESIONS, ALONG WITH A BANKART INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970406 BIO-COMP-SITE P-LCK 2.9X15.5MM BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP-SITE P-LCK 2.9X15.5MM 15031453 00888867023017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown