BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPUY PATELLA CUTTING DEVICE

    MDR report key: 7689263 · Received July 13, 2018

    Report

    Report Number
    MW5078379
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 28, 2018
    Report Date
    July 11, 2018
    Manufacturer
    DEPUY SYNTHES, INC.
    Product Code
    HTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TKA, AN INSTRUMENT BROKE AND SMALL PART CAME OFF OF PATELLA CUTTING GUIDE. X-RAY CALLED AND IMAGES OF KNEE TAKEN AND READ PER SURGEON. STERILE FIELD EXAMINED FOR PIECE AND MAGNET USED ON FLOOR. PIECE FOUND ON FLOOR AND COMPARED TO BROKEN INSTRUMENT OFF OF STERILE FIELD, SURGEON EXAMINED PIECE AS WELL. PICTURE TAKEN BY INDUSTRY REP STATING HE WILL SHOW PICTURE TO MGR OF OPERATING ROOM. INSTRUMENT WAS FLAGGED WITH A REPAIR TAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528382 DEPUY PATELLA CUTTING DEVICE INSTRUMENT, CUTTING, ORTHOPEDIC HTZ DEPUY SYNTHES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR