BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3813240 · Received March 27, 2014

    Report

    Report Number
    8031000-2014-00205
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    October 11, 2013
    Report Date
    March 24, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 11/28/2012. EVALUATION OF THE DEVICE OBSERVED THAT EVERY DEVICE DISPLAYED POSITIONS WHERE PINS WERE NO LONGER ATTACHED TO THE MOUNTED DRIVE SHAFT. THE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL OSCILLATING SAW ATTACHMENT BLADE WAS STUCK IN THE SAW ATTACHMENT, THE LOCKING MECHANISM IS NOT OPENING. THERE WAS NO PATIENT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179632 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1