BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3123979 · Received May 15, 2013

    Report

    Report Number
    8031000-2013-00036
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TOTAL HIP ARTHROPLASTY WHILE USING THE OSCILLATING SAW, IT WAS DISCOVERED THE SAW BLADE ON THE ZIMMER UNIVERSAL OSCILLATING SAW ATTACHMENT WAS LOOSE. IT WAS REPORTED THAT THE PINS THAT HOLD THE SAW BLADE IN PLACE WERE SHEARED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. IT WAS REPORTED THAT THE PROCEDURE WAS DELAYED BETWEEN TWO AND THREE MINUTES WHILE THE ALTERNATE DEVICE WAS OBTAINED. NO ADD'L CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214522 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1