BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROUND BUR - MEDIUM

    MDR report key: 1915268 · Received November 2, 2010

    Report

    Report Number
    9616696-2010-00323
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 6, 2010
    Manufacturer
    STRYKER IRELAND LTD
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR SUBJECT TO THIS INVESTIGATION WAS NOT AVAILABLE FOR INVESTIGATION, IT WAS DISCARDED. THE MFG RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL SHOULDER PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS REMOVED FROM THE SURGICAL SITE USING A HAEMOSTAT. IT WAS FURTHER REPORTED THAT THE SURGEON HAS NOT CONCERNS ABOUT ANY PIECES BEING LEFT BEHIND IN THE PT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND BUR - MEDIUM DRILLS, BURS, TREPHINES & ACCESSORIES HBF STRYKER IRELAND LTD 10165017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK