BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23312626 · Received October 16, 2025

    Report

    Report Number
    1220246-2025-04651
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    August 13, 2025
    Report Date
    February 2, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867023017
    PMA / PMN Number
    K173240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 BY THE ATTACHED PICTURE, WHICH SHOWS THAT THE SCREW WAS BROKEN OFF. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. PER DFU-0087-EO - E. WARNINGS - 6. BIOABSORBABLE ONLY: ATTEMPTING IMPLANTATION INTO HARD, DENSE BONE AND/OR DRILLING/PUNCHING SMALLER DIAMETER HOLES THAN RECOMMENDED MAY CAUSE FAILURE (BREAKAGE) OF THE IMPLANT DURING INSERTION. G. PRECAUTIONS - 3. MAKE SURE TO USE THE RECOMMENDED DRILL BIT OR PUNCH TO CREATE THE BONE SOCKET. THE QUALITY OF THE BONE ENCOUNTERED WAS NOT SPECIFIED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO IMPROPER BONE PREPARATION, MISALIGNMENT INSERTION, AND/OR PRYING/LEVERAGING OF THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 10/08/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1923BC BIOCOMPOSITE PUSHLOCK SCREW FRACTURED INTO MULTIPLE PIECES, LEAVING IT CRACKED ON ALL SIDES. DURING THE PROCEDURE, TWO AR-1923BC BIOCOMPOSITE PUSHLOCK ANCHORS WERE SUCCESSFULLY PLACED. WHEN ATTEMPTING TO PLACE A THIRD ANCHOR, WHICH WAS FROM A DIFFERENT LOT THAN THE PREVIOUS TWO, THE SAME STANDARD PLACEMENT TECHNIQUE WAS USED. THE SURGEON POSITIONED THE PURPLE GUIDE, THE PUNCH WAS REMOVED, AND THE GUIDE WAS IMPACTED TO SECURE IT IN PLACE. DRILLING WAS PERFORMED TO THE STOP USING A 2.9 MM DRILL BIT. THE LABRAL TAPE ENDS WERE THREADED, AND THE GUIDE WAS REMOVED TO ALLOW INSERTION OF THE ANCHOR. UPON INITIAL IMPACT TO INSERT THE ANCHOR, IT FRACTURED INTO SEVERAL PIECES. ALTHOUGH THE ANCHOR WAS IMPACTED TO THE INTENDED DEPTH, IT FAILED STRUCTURALLY AND WAS REMOVED. THE CASE WAS COMPLETED USING A PEEK ANCHOR AS A REPLACEMENT. IT WAS NOTED THAT THE SURGEON MAINTAINED FIRM CONTROL OF THE HANDLE THROUGHOUT THE PLACEMENT TO ENSURE PROPER ALIGNMENT. THIS EVENT OCCURRED DURING A PROCEDURE ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2392301 BIO-COMP-SITE P-LCK 2.9X15.5MM BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP-SITE P-LCK 2.9X15.5MM 15094040 00888867023017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown