BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5

    MDR report key: 1902168 · Received November 16, 2010

    Report

    Report Number
    1902168
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BONE SAW WOULD NOT WORK. THE DEVICE WAS TESTED PRIOR TO USE AND WOULD NOT WORK. THE SAW IS STILL UNDER CONTRACT WITH STRYKER AND THE BIOMEDICAL ENGINEER SENT THE SAW BACK TO STRYKER TO HAVE IT REPAIRED.====================== MANUFACTURER RESPONSE FOR BONE SAW, STRYKER BONE SAW======================UNDER CONTRACT, THE DEVICE WAS SENT TO THE MANUFACTURER TO INVESTIGATE THE PROBLEM AND COMPLETE REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 5 BONE SAW HWE STRYKER INSTRUMENTS 4208-000-000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *