BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2930086 · Received January 23, 2013

    Report

    Report Number
    2930086
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 23, 2013
    Manufacturer
    *
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN WAS USING THE BUCKWALTER, A METAL PIECE FROM RATCHET BROKE OFF. THE PIECE WAS FOUND AND THE INSTRUMENT WAS REMOVED FROM SERVICE. AN X-RAY WAS TAKEN AT THE END OF THE CASE AND A SECOND X-RAY TAKEN PER PHYSICIAN AND READ AS INCONCLUSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32151 * RATCHET GAD * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR