BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3807329 · Received March 19, 2014

    Report

    Report Number
    8031000-2014-00162
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 06/04/2012. EVAL OF THE DEVICE OBSERVED THAT EVERY DISPLAYED POSITIONS PINS WERE NO LONGER ATTACHED TO THE MOUNTED DRIVE SHAFT. THE CURRENT CAUSE OF THE BROKEN PINS ON THE MOUNTED DRIVE SHAFT OF THE OSCILLATING SAW IS CURRENTLY UNDETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OSCILLATING SAW ATTACHMENT WAS NOT WORKING PROPERLY. THERE WAS NO PT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163430 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1