BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS STERNAL SAW II

    MDR report key: 78079 · Received March 20, 1997

    Report

    Report Number
    1828100-1997-00004
    Event Type
    Malfunction
    Date Received
    March 20, 1997
    Date of Event
    February 24, 1997
    Report Date
    March 20, 1997
    Manufacturer
    3M HEALTH CARE, SARNS 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

    DURING USE THE SCREW ON THE TOP OF THE SAW CAME OUT AND FELL INSIDE THE PT. THE SCREW WAS 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 SURGICAL SAW DWH 3M HEALTH CARE, SARNS AND CDI PRODUCTS 98-0702-0597-0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention