BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 4110188 · Received September 11, 2014

    Report

    Report Number
    8031000-2014-00310
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 1, 2014
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    PHYSICIAN

    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 IS REPORTED THAT THE UNIVERSAL OSCILLATING SAW ATTACHMENT "TEETH GOT BROKEN" (I.E., THE BLADE LOCKING MECHANISM PINS/TEETH OF THE ATTACHMENT WERE BROKEN). THE EVENT OCCURRED PRIOR TO SURGERY AND THERE WAS NO HARM TO THE PATIENT/USER AND THERE WAS NO EXTENSION OR DELAY IN SURGERY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562463 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1