BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACUT

    MDR report key: 1696005 · Received May 20, 2010

    Report

    Report Number
    1696005
    Event Type
    Malfunction
    Date Received
    May 20, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ZIMMER
    Product Code
    HWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE ZIMMER OSTEOTOME BROKE OFF IN THE PATIENT WHEN DOING AN ORTHOPEDIC PROCEDURE. THE TIP WAS LEFT IN THE PATIENT BECAUSE RETRIEVAL WOULD CAUSE FURTHER DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACUT ELEVATOR HWM ZIMMER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *