BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIOVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3905230 · Received May 28, 2014

    Report

    Report Number
    8031000-2014-00255
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    January 31, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ZIMMER SUGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OSCILLATING SAW ATTACHMENT (B)(4) WAS RETURNED FOR COMPLAINT INVESTIGATION. UPON RECEIPT, IT HAS BEEN CONFIRMED THAT THE ATTACHMENT WAS FUNCTIONAL BUT THAT SOME PINS WERE NO LONGER ATTACHED TO THE MOUNTED DRIVE SHAFT. NO OTHER EXTERNAL DAMAGE WAS OBSERVED. THE DEVICE COULDN'T BE REPAIRED. THE ROOT CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL OSCILLATING SAW ATTACHMENT DOESN'T WORK. THERE WAS NO PT HARM OR DELAY REPORTED AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314820 UNIOVERSAL OSCILLATING SAW ATTACHMENT UNIOVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SUGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1