BEUDAMED
    FDA Adverse Event Death Summary report: N

    HALL STERNUM SAW (PNEUMATIC)

    MDR report key: 624817 · Received August 5, 2005

    Report

    Report Number
    1017294-2005-00156
    Event Type
    Death
    Date Received
    August 5, 2005
    Date of Event
    May 20, 2005
    Report Date
    July 8, 2005
    Manufacturer
    LINVATEC CORPORATION
    Product Code
    KFK
    Adverse Event
    Yes
    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 07/05, 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. THEY THEN REPORTED THAT A PT HAD EXPIRED AND THAT ANY TYPE OF DELAY IN ASSEMBLING THE SAW BLADE AND STERNUM SAW WOULD BE UNACCEPTABLE. THE REPORTER CONFIRMED TO THE SALES REPRESENTATIVE AND LINVATEC THAT THIS STERNUM SAW WAS NOT USED ON THE PT. THE PT DIED FROM A RUPTURED AORTA. THEIR DEATHE WAS NOT ASSOCIATED WITH THE DEVICE. LINVATEC REQUESTED THE STERNUM SAW TO BE RETURNED FOR INVESTIGATION, BUT REPEATED ATTEMPTS TO OBTAIN THE DEVICE HAVE GONE UNANSWERED. THEY DID REPORT THAT THE STERNUM SAW HAS BEEN SENT TO RISK MANAGEMENT. THEY ALSO REPORTED THAT THEY UTILIZE A 3RD PARTY REPAIR FACILITY, BUT ATTEMPTS BY LINVATEC REGULATORY TO OBTAIN THE NAME OF THIS FACILITY WERE NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death