BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 2177008 · Received November 6, 2008

    Report

    Report Number
    2177008
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 5, 2008
    Manufacturer
    BIOMET ORTHOPEDICS, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEFT TOTAL KNEE ARTHROPLASTY PERFORMED ON PATIENT ON (B)(6) 2008. DURING PROCEDURE ONE OF THE PINS FRACTURED LEAVING A REMNANT OF THE PIN INSIDE THE FEMUR. SURGEON DETERMINED THAT RETRIEVAL WOULD BE MORE HARMFUL THAN GOOD SO MADE DECISION TO LEAVE PIN REMNANT IN FEMUR. PATIENT INFORMED AFTER SURGERY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET QUICK RELEASE DRILL 3.2MM HTW BIOMET ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other