BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWITCHCUT REAMER 4.5 X 10.0MM W/ NITINOL PASSERS

    MDR report key: 6967648 · Received October 22, 2017

    Report

    Report Number
    8043971-2017-00002
    Event Type
    Malfunction
    Date Received
    October 22, 2017
    Date of Event
    June 8, 2017
    Report Date
    July 10, 2017
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    HTO
    UDI-DI
    10810190013899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SWITCH CUT WAS REAMED ON TO GRADE FROM LATERAL CORTEX OF FEMUR IN TO FEMORAL NOTCH. REVERSED REMER TO RETROGRADE REAMER FEMORAL SOCKET AND THE SWITCH CUT BLADE CAUGHT AT THE TOP OF THE NOTCH AND BROKE OFF * 3 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747228 SWITCHCUT REAMER 4.5 X 10.0MM W/ NITINOL PASSERS SWITCHCUT REAMER 4.5 X 10.0MM W/ NITINOL PASSERS HTO T.A.G. MEDICAL PRODUCTS CORPORATION LTD 110027682 16K06 10810190013899

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR