BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERCONDYLAR FEMORAL CHISEL

    MDR report key: 1040872 · Received May 1, 2008

    Report

    Report Number
    1040872
    Event Type
    Malfunction
    Date Received
    May 1, 2008
    Date of Event
    March 17, 2008
    Report Date
    May 1, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LZV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, WHILE THE PHYSICIAN WAS USING AN INTERCONDYLAR CHISEL DEEP IN THE PATIENT'S FEMORAL CANAL, THE 1/2 X 1 CM (ESTIMATED) SPIKE AT THE END OF THE INSTRUMENT BROKE OFF AND FELL DISTAL. THE PHYSICIAN WAS NOT ABLE TO EXTRACT THE SPIKE FROM THE FEMORAL CANAL. PIECE WAS VISUALIZED ON X-RAY WITH RESULTS AS FOLLOWS: A SINGLE AP VIEW OF THE DISTAL RIGHT FEMUR AND RIGHT KNEE JOINT DEMONSTRATES A 2.6 CM LONG METALLIC DENSITY PROJECTED OVER THE DISTAL RIGHT FEMORAL DIAMETAPHYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERCONDYLAR FEMORAL CHISEL CHISEL, CEMENT, FEMORAL CANAL LZV DEPUY ORTHOPAEDICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR