BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS STERNAL SAW II

    MDR report key: 71938 · Received February 21, 1997

    Report

    Report Number
    1828100-1997-00002
    Event Type
    Malfunction
    Date Received
    February 21, 1997
    Date of Event
    January 22, 1997
    Report Date
    February 21, 1997
    Manufacturer
    3M HEALTH CARE SARNS AND CDI PRODUCTS
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAS HAD TO REPLACE THEIR STERNAL SAW PROTECTORS APPROXIMATELY TWENTY TIMES IN THE PAST YEAR DUE TO DEFORMATION OF THE FOOTPIECE. UPON INVESTIGATION OF THIS PROBLEM, IT WAS DISCOVERED THAT THE CUSTOMER HAS BEEN USING ANOTHER MFR'S BLADE WITH THE STERNAL SAW. THIS BLADE DOES NOT FIT EXACTLY INTO THE BLADE RETAINING MECHANISM (IT IS TOO LARGE FOR THE BALDE RETAINING MECHANISM). AS A RESULT OF THIS MISMATCH, THERE IS THE POSSIBILITY THAT THESE BLADES COULD BE EJECTED FROM THE BLADE RETENTION MECHANISM AND INTO THE THORACIC CAVITY DURING USE. THE CUSTOMER HAS NOT REPORTED ANY BLADES BEING EJECTED, NOR HAVE THEY REPORTED ANY INJURIES 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 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other