BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLIPCUTTER

    MDR report key: 3232373 · Received July 8, 2013

    Report

    Report Number
    3232373
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 8, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN USING A FLIPCUTTER II 10 MM (CATALOG NUMBER: AR-1204AF-100, LOT NUMBER: 305939889, EXPIRATION DATE: 2018-03) TO MAKE TUNNEL FOR ACL AUTOGRAFT IMPLANTATION THE TIP OF THE FLIPCUTTER II BROKE INTO THE JOINT. THE ORTHOPEDIC SURGEON RETRIEVED THE BROKEN TIP OF FLIPCUTTER II AND PROCEEDED WITH THE CASE. THE ARTHREX TECHNICAL REPRESENTATIVE WAS IN THE OR AT THE TIME OF THE INCIDENT. THE FLIPCUTTER II WAS TAKEN BY THE MANUFACTURER REPRESENTATIVE FOR PRODUCT EVALUATION.======================MANUFACTURER RESPONSE FOR FLIPCUTTER II, FLIPCUTTER (PER SITE REPORTER).======================NO RESPONSE YET.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ACL RECONSTRUCTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309314 FLIPCUTTER ARTHROSCOPE HRX ARTHREX, INC. II 305939889

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR