BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 4110177 · Received September 11, 2014

    Report

    Report Number
    8031000-2014-00307
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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 DURING KIT INSPECTION, THE UNIVERSAL OSCILLATING SAW ATTACHMENT WAS NOTED TO "LACK OF TOOTH TO SET THE SAW" (I.E., PINS WERE NOTED AS MISSING IN THE BLADE LOCKING MECHANISM). THERE WAS NO EXTENSION IN SURGERY TIME, NO HARM, INJURY OR ADVERSE EVENT TO PATIENT/OPERATOR AND NO MEDICAL INTERVENTION/ADDITIONAL SURGICAL PROCEDURE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563100 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1