BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BIGLIANI FLATOW DRILL GUIDE

    MDR report key: 1970905 · Received January 4, 2011

    Report

    Report Number
    1822565-2011-00009
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 IS REPORTED THAT THE SURGERY WAS DELAYED 30 MINUTES WHEN THE SURGEON HAD TO BEND THE DRILL GUIDES IN ORDER TO GET THEM TO SEAT IN THE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER BIGLIANI FLATOW DRILL GUIDE SHOULDER INSTRUMENT HSD ZIMMER INC 61313436

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR CATALOG# 00430703246| BIGLIANA/FLATOW THE COMPLETE SHOULDER SOLUTION| LOT# 61334904| TRABECULAR METAL GLENOID INSTRUMENT DRILL GUIDE