BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3880771 · Received April 9, 2014

    Report

    Report Number
    8031000-2014-00216
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 30, 2014
    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 MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON (B)(4) 2012. EVALUATION OF THE DEVICE OBSERVED THAT EVERY DEVICE DISPLAYED POSITONS WHERE PINS WERE NO LONGER ATTACHED TO THE MOUNTED DRIVE SHAFT. THE CAUSE OF THE REPORTED ISSUE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT REPORTED THAT THE UNIVERSAL OSCILLATING SAW ATTACHMENTS WERE DAMAGED DURING SURGERY. THERE WAS NO PATIENT HARM OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214024 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNIVERSAL OSCILLATING SAW ATTACHMENT 227882| UNIVERSAL OSCILLATING SAW ATTACHMENT 227871