BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE HOLDING CLAMP, 7"

    MDR report key: 1155026 · Received June 19, 2008

    Report

    Report Number
    2430952-2008-00010_2
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT THE TIPS OF THE INSTRUMENT ARE WEAK AND BROKE DURING USE. THE INSTRUMENT WAS DISCARDED BY THE HOSP AND THEREFORE, IS NOT AVAILABLE FOR EVAL. THE INSTRUMENT WAS IN CONTACT WITH THE PT, BUT THERE WAS NO INJURY REPORTED. ON 5/2/2008 ADD'L INFO NOTED IN THE COMMUNICATION SECTION OF THIS FILE INDICATES THAT THE USER FACILITY REPORTED THAT THE TIPS OF THE INSTRUMENT WERE RECOVERED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEWIN BONE HOLDING CLAMP, 7" JARIT ORTHOPEDIC SURGERY DXC HEBUMEDICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *