BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK REAMERS 7MM, 8MM 9MM

    MDR report key: 46295 · Received October 29, 1996

    Report

    Report Number
    1221934-1996-00001
    Event Type
    Malfunction
    Date Received
    October 29, 1996
    Date of Event
    May 31, 1996
    Report Date
    October 18, 1996
    Manufacturer
    MITEK SURGICAL PRODUCTS, INC.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOUR REAMERS WERE RETURNED BROKEN AT THE WELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK REAMERS 7MM, 8MM 9MM ORTHOPEDIC REAMER HTO MITEK SURGICAL PRODUCTS, INC. * 941028, 940678

    Patients

    Seq Age Sex Outcome Treatment
    1 *