BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3070575 · Received April 17, 2013

    Report

    Report Number
    8031000-2013-00018
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    September 1, 2012
    Report Date
    September 25, 2013
    Manufacturer
    ZIMMER SURGICAL S.A,
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL OSCILLATING SAW ATTACHMENT STARTED TO FALL APART DURING THE OPERATION. NO ADD'L CLINICAL INFO WAS REC'D PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164658 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A, NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1