BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3241102 · Received July 18, 2013

    Report

    Report Number
    8031000-2013-00127
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    April 9, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVALUATION. EVALUATION OF THE DEVICE OBSERVED THAT TWO OF THE EIGHT HUB PINS WERE NO LONGER ATTACHED TO THE MOUNTED DRIVE SHAFT. THE CAUSE OF THE REPORTED ISSUE IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL OSCILLATING SAW ATTACHMENT HAD A BROKEN KNOB. ADD'L CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THE ISSUE WAS OBSERVED DURING AN INSPECTION PROCESS AND THE DEVICE WAS NOT IN USER OR INTENDED FOR ANY SCHEDULED PROCEDURE AT THE TIME OF INSPECTION. THERE WAS NO REPORT OF PT HARM. EVALUATION OF THE RETURNED DEVICE IDENTIFIED THAT TWO OF THE EIGHT HUB PINS WERE NO LONGER ATTACHED TO THE MOUNTED DRIVE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336506 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1