BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OCILLATING SAW ATTACHMENT

    MDR report key: 3831839 · Received March 6, 2014

    Report

    Report Number
    8031000-2014-00110
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 7, 2014
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; 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 STIFFED AND STOPPED DURING SURGERY AND DID NOT WORK AGAIN. THERE WAS NO PATIENT HARM; HOWEVER THERE WAS A DELAY IN SURGERY FOR APPROXIMATELY 20 MINUTES. THE PROCEDURE COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135807 UNIVERSAL OCILLATING SAW ATTACHMENT UNIVERSAL OCILLATING SAW ATTACHMENT GEY ZIMMER SURGICAL S.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1