BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCISSOR, 3.4MM , L CURVED STR W/WB

    MDR report key: 22736454 · Received August 7, 2025

    Report

    Report Number
    1220246-2025-03298
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 18, 2025
    Report Date
    October 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867005273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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: D9, G3, H3, H6. - ONE UNPACKAGED AR-12160W, WISHBONE¿ SCISSOR, BATCH 10244516, WAS RECEIVED FOR INVESTIGATION. - VISUAL INSPECTION NOTED THAT THE CUTTING EDGES HAD NICKS/DAMAGE, AND THE LOWER CUTTING BLADE WAS CRACKED. - FUNCTIONAL TESTING NOTED THAT THE DRIVER FUNCTIONS AS INTENDED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, WHICH CAN BE ATTRIBUTED TO PRYING/LEVERAGING THE DEVICE WITH EXCESSIVE FORCE DURING USE. - REFER TO THE INVESTIGATION PHOTOS. - COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 07/18/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-12160W WISHBONE¿ SCISSOR SERRATED JAW SNAPPED OFF. THE ISSUE WAS DISCOVERED DURING THE SURGERY. ANOTHER DEVICE WAS SWAPPED, AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505212 SCISSOR, 3.4MM , L CURVED STR W/WB MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. SCISSOR, 3.4MM , L CURVED STR W/WB 10244516 00888867005273

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown