BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL OSCILLATING SAW ATTACHMENT

    MDR report key: 3802666 · Received February 25, 2014

    Report

    Report Number
    8031000-2014-00092
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 28, 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; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER UNIVERSAL OSCILLATING SAW ATTACHMENT HAD PINS THAT BROKE OFF DURING SURGERY. X-RAYS WERE MADE TO SEE IF ANY BROKEN PARTS FELL INTO THE WOUND. NO PARTS WERE OBSERVED ON THE X-RAY. SURGERY TIME WAS EXTENDED TWO MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116030 UNIVERSAL OSCILLATING SAW ATTACHMENT UNIVERSAL OSCILLATING SAW ATTACHMENT GFA ZIMMER SURGICAL S.A. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1