BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENO SCRW,BIO-COMP

    MDR report key: 23366400 · Received October 23, 2025

    Report

    Report Number
    1220246-2025-04768
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 10, 2025
    Report Date
    February 24, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867018945
    PMA / PMN Number
    K051726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE OF AN AR-1570BC, BATCH 15432086, THAT DISPLAYS PIECES OF THE BIOCOMPOSITE TENODESIS SCREW. 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. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO USER-APPLIED EXCESSIVE MECHANICAL FORCES OR IMPROPER PLACEMENT OF THE DEVICE. PER THE DIRECTIONS FOR USE (DFU) DFU-0111-EO REVISION 3, INTERFERENCE SCREWS E. WARNINGS 7. PREOPERATIVE AND OPERATING PROCEDURES, INCLUDING KNOWLEDGE OF SURGICAL TECHNIQUES AND PROPER SELECTION AND PLACEMENT OF THE DEVICE, ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THIS DEVICE. THE APPROPRIATE ARTHREX DELIVERY SYSTEM IS REQUIRED FOR PROPER IMPLANTATION OF THE DEVICE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 10/14/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1570BC BIOCOMPOSITE TENODESIS SCREW BROKE DURING THE PASSAGE OF AN FHL ¿ ACHILLES TENDON TRANSFER. IT REMAINED LODGED WITH ONLY HALF ITS LENGTH AND HELD THE GRAFT IN PLACE. A REINFORCEMENT WAS APPLIED TO THE TENDON. THE SURGICAL TECHNICIAN REPORTED THAT THE TECHNIQUE WAS CORRECTLY PERFORMED AND THAT NO FRAGMENTS WERE LEFT BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930280 TENO SCRW,BIO-COMP BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. TENO SCRW,BIO-COMP 15432086 00888867018945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown