BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3810795 · Received March 21, 2014

    Report

    Report Number
    8031000-2014-00188
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    March 1, 2013
    Report Date
    September 10, 2013
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 11/28/2012. EVAL OF THE DEVICE OBSERVED THAT EVERY DEVICE DISPLAYED POSITIONS WHERE PINS WERE NO LONGER ATTACHED TO THE MOUNTED DRIVE SHAFT. THE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL OSCILLATING SAW ATTACHMENT THE PIN BROKE OFF AFTER COMING INTO CONTACT WITH A SYNTHETIC BONE DURING A WORKSHOP. NO ADD'L CLINICAL INFO WAS REC'D PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170177 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1