BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALL STERUM

    MDR report key: 2900839 · Received December 18, 2012

    Report

    Report Number
    2900839
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    April 2, 2012
    Report Date
    December 18, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    KFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE OPENING, THE PNEUMATIC POWERED STERNUM SAW HAD A CONNECTOR HOSE RUPTURE THAT RESULTED IN NO INJURIES, BUT RE-PREPPING OF THE CHEST AREA FOR STERILITY. ANOTHER PNEUMATIC POWERED STERNUM SAW WAS OBTAINED, AND MEDIAN STERNOTOMY COMPLETED WITHOUT FURTHER INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALL STERUM HANDPIECE, SAW, PNEUMATIC KFK CONMED CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR