BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE HOLDING CLAMP, 7"

    MDR report key: 1145464 · Received May 30, 2008

    Report

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

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE MANUFACTURER COULD NOT PERFORM A COMPLETE EVALUATION AND DETERMINE THE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT (5) FIVE PREVIOUS SIMILAR COMPLAINTS WERE REPORTED. CAPA WAS INITIATED AFTER THE SECOND REPORTABLE INCIDENT TO MINIMIZE ANY FUTURE OCCURRENCE. THIS CHANGE WAS DESIGNED TO PROVIDE ADDITIONAL STRENGTH TO THE DEVICE TIP. INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR J. JAMNER SURGICAL INSTRUMENTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE TIPS OF THE INSTRUMENT ARE WEAK AND BROKE DURING USE. THE INSTRUMENT WAS DISCARDED BY THE HOSPITAL AND THEREFORE IS NOT AVAILABLE FOR EVALUATION. THE INSTRUMENT WAS IN CONTACT WITH THE PATIENT, BUT THERE WAS NO INJURY REPORTED. ON 05/02/2008, ADDITIONAL INFORMATION NOTED IN THE COMMUNICATION SECTION OF THIS FILE INDICATES THAT THE USER FACILITY REPORTED THAT THE TIPS OF THE INSTRUMENT WERE RECOVERED FROM THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1