BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Ø8X 20MM BC IF SCRW, VENTED

    MDR report key: 23828389 · Received December 17, 2025

    Report

    Report Number
    1220246-2025-05660
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 25, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867276963
    PMA / PMN Number
    K202535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. -COMPLAINT ALLEGATION IS CONFIRMED. -VISUAL INSPECTION OF THE FASTTHREAD¿ BIOCOMPOSITE¿ INTERFERENCE SCREW 8 X 20 MM, IDENTIFIED THAT THE SCREW WAS BROKEN OFF; ONLY ONE HALF OF THE SCREW WAS RETURNED FOR INVESTIGATION. -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 SPECIFIED. PER DFU-0111-EO - G. PRECAUTIONS - 4. BIO-TENODESIS SCREW ONLY: USE THE APPROPRIATE SIZE ARTHREX DRILL TO CREATE A PILOT HOLE IN THE BONE. 6. BIO-ABSORBABLE INTERFERENCE SCREW ONLY: IT IS IMPORTANT TO COMPLETELY SEAT THE SCREWDRIVER TO PREVENT POTENTIAL STRIPPING OF THE HEX AND/OR SCREW FRACTURE DURING INSERTION OR REMOVAL. THE MOST LIKELY CAUSE FOR 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.

    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

    IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BROKE. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE DW (B)(6) 2025: FURTHER INFORMATION WAS PROVIDED THAT THE FRAGMENT REMAINED INSIDE THE PATIENT AND WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040097 Ø8X 20MM BC IF SCRW, VENTED BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. Ø8X 20MM BC IF SCRW, VENTED 15281063 00888867276963

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown