BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.5 MM FLIP CUTTER II

    MDR report key: 23094975 · Received September 19, 2025

    Report

    Report Number
    1220246-2025-03950
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    September 1, 2025
    Report Date
    September 26, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867004122
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. 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 THE MOST LIKELY CAUSE. THE FAILURE WAS LIKELY DUE TO USER ERROR, SUCH AS IMPROPER BONE PREPARATION, MISALIGNED INSERTION, OR EXCESSIVE FORCE DURING DRILLING, WHICH MAY HAVE EXCEEDED THE DEVICE¿S STRUCTURAL LIMITS AND CAUSED THE TIP TO BREAK. THE COMPLAINT ALLEGATION COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE REPORTED FAILURE WAS PROVIDED.

    Description of Event or Problem · 0

    ON 2ND SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1204AF-105, FLIPCUTTER® II, 10.5 MM, THE TIP BROKE WHILE DRILLING. THIS WAS DETECTED DURING A PCL RECONSTRUCTION WITH ALLOGRAFT AND INTERNAL BRACE ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1204AF-105. THE TIP WAS BREAK OFF INSIDE THE PATIENT AND THE BROKEN PIECE WAS NOT RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760728 10.5 MM FLIP CUTTER II MANUAL INSTR, GENERAL SURGICAL HWE ARTHREX, INC. 10.5 MM FLIP CUTTER II 3276135445 00888867004122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown