BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 227989 · Received June 18, 1999

    Report

    Report Number
    227989
    Event Type
    Malfunction
    Date Received
    June 18, 1999
    Date of Event
    June 15, 1999
    Report Date
    June 18, 1999
    Manufacturer
    BIOMET, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 6/15/99 PT SENT TO O.R. FOR INTERMEDULLARY RODDING LEFT FEMUR. RADIOLUCENT TARGETING DEVICE TIP BROKE OFF AND LEFT IN FEMUR DURING SURGERY. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET RADIOLUCENT TARGETING DEVICE DRILL ADAPTOR HTW BIOMET, INC. 471845 477870

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other