BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX 5.5 MM CUTTER

    MDR report key: 2982680 · Received February 21, 2013

    Report

    Report Number
    MW5029139
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ARTHREX INC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORTHOPEDIC SURGEON WAS USING A SCOPE DURING A PROCEDURE AND THE ARTHREX SHAVER BEGAN MAKING AN UNUSUAL NOISE. THE SHAVER WAS WITHDRAWN AND THE TIP OF THE DISPOSABLE PORTION WAS NOTED TO HAVE A PART OF THE METAL BROKEN OFF. SHAVER REPLACED AND SURGERY CONTINUED AFTER REMOVAL OF METAL FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75759 ARTHREX 5.5 MM CUTTER BONE SHAVER HRX ARTHREX INC A818421

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention