BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGLIANI/FLATOW CANNULATED DRILL

    MDR report key: 3820020 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00619
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ZIMMER INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BIT BROKE OFF IN THE PT DURING THE COURSE OF OPERATION CAUSING A PNEUMOTHORAX. THE PT RETURNED FOR SURGERY THE FOLLOWING DAY AND THE DRILL BIT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288737 BIGLIANI/FLATOW CANNULATED DRILL HSD ZIMMER INC. 62529517

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention