BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL REAMER 8.0MM

    MDR report key: 1170693 · Received September 10, 2008

    Report

    Report Number
    1170693
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    June 20, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THE HEAD OF THE ZIMMER SENTINEL REAMER SIZE 8 BROKE OFF WHILE BEING USED TO REAM THE FEMUR CAUSING THE SHAFT OF THE REAMER TO BREAK INTO MULTIPLE PIECES INSIDE THE PATIENT'S FEMUR. PHYSICIAN WAS ABLE TO REMOVE ALL PIECES FROM PATIENT WITH C-ARM, AND COMPLETED THE CASE WITHOUT INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTINEL REAMER 8.0MM REAMER,ORTHOPEDIC HTO ZIMMER, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR