BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDER SOLUTION PFJ MILLING BURR

    MDR report key: 1860208 · Received September 21, 2010

    Report

    Report Number
    1822565-2010-00791
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE BURR BECAME STUCK IN THE DRILL GUIDE RESULTING IN THE SURGEON RESORTING TO FREE HAND BURRING AND A 60 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENDER SOLUTION PFJ MILLING BURR KNEE INSTRUMENT LXH ZIMMER, INC. 61510663

    Patients

    Seq Age Sex Outcome Treatment
    1