BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROTEK

    MDR report key: 820169 · Received January 30, 2007

    Report

    Report Number
    820169
    Event Type
    Injury
    Date Received
    January 30, 2007
    Date of Event
    December 6, 2006
    Report Date
    December 19, 2006
    Manufacturer
    BIOMET ORTHOPEDICS, INC.
    Product Code
    HTW
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DURING AN ACL PROCEDURE, THE TIP OF THE OVERDRILL (CROSS-PIN REAMER) BROKE OFF AS IT WAS BEING DRILLED INTO THE FEMUR. AS A RESULT, THERE WERE TWO METALLIC FRAGMENTS EMBEDDED WITHIN THE BONE. NO APPARENT INJURY TO THE PT, AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROTEK 4MM AXL CROSS-PIN REAMER HTW BIOMET ORTHOPEDICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention