BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALL STERNUM SAW (PNEUMATIC)

    MDR report key: 628547 · Received August 5, 2005

    Report

    Report Number
    1017294-2005-00165
    Event Type
    Malfunction
    Date Received
    August 5, 2005
    Report Date
    July 8, 2005
    Manufacturer
    LINVATEC CORP.
    Product Code
    KFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED DIFFICULTY IN INSERTING SAW BLADES INTO THEIR STERNUM SAWS AND IN 2005, THE SALES REPRESENTATIVE WAS AT THE FACILITY PERFORMING THIS PRODUCT TRAINING. THE USER REPORTED THAT THEY WERE CONCERNED WITH ANY TYPE OF DELAY IN INSERTING A SAW BLADE INTO THE STERNUM SAW. MDR 1017294-2005-000156.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL STERNUM SAW (PNEUMATIC) STERNUM SAW PNEUMATIC KFK LINVATEC CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *