BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REA

    MDR report key: 460615 · Received May 14, 2003

    Report

    Report Number
    1822565-2003-00071
    Event Type
    Injury
    Date Received
    May 14, 2003
    Date of Event
    April 3, 2003
    Report Date
    April 7, 2003
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON PROCEEDED TO PERFORM INITIAL REAMING OF TIBIAL CANAL FOR AN MDN NAIL USING 8.0 MM REAMER. REAMER SHATTERED INTO MULTIPLE FRAGMENTS IN PROXIMAL TIBIAL CANAL. ALMOST ALL OF THE FRAGMENTS WERE RETRIEVED WITH A FEW REMAINING BEHIND. MDN NAIL SURGERY COMPLETED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REA FLEXIBLE REAMER HTO ZIMMER, INC. NA 73228100

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R