BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW ATTACH

    MDR report key: 3896032 · Received May 15, 2014

    Report

    Report Number
    8031000-2014-00239
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING KIT INSPECTION, IT WAS NOTED THAT THE OSCILLATING SAW ATTACHMENT HAS A PIN THAT IS MISSING. THERE WAS NO PATIENT HARM OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291046 OSCILLATING SAW ATTACH OSCILLATING SAW ATTACH GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1