BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS STERNAL SAW II

    MDR report key: 55438 · Received October 1, 1996

    Report

    Report Number
    1828100-1996-00002
    Event Type
    Malfunction
    Date Received
    October 1, 1996
    Date of Event
    August 16, 1996
    Report Date
    September 19, 1996
    Manufacturer
    3M HEALTH CARE, SARN AND CDI PRODUCTS
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER THE SURGEON FINISHED SAWING THE STERNUM, THE TIP OF THE BLADE PROTECTOR FELL INTO THE PT. THE TIP WAS IMMEDIATELY RETRIEVED FROM THE PT. NO PT INJURY WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS STERNAL SAW II STERNAL SAW DWH 3M HEALTH CARE, SARN AND CDI PRODUCTS 5590 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention