BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPROCESSED STRYKER STERNUM SAW BLADE

    MDR report key: 964925 · Received December 11, 2007

    Report

    Report Number
    2134070-2007-00017
    Event Type
    Malfunction
    Date Received
    December 11, 2007
    Date of Event
    November 29, 2007
    Report Date
    December 11, 2007
    Manufacturer
    STERILMED, INC.
    Product Code
    DZH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LIMITED INFORMATION ABOUT THE EVENT WAS PROVIDED BY THE USER FACILITY. 100% OF LIKE DEVICES ARE INSPECTED BY STERILMED. THE DEVICE IN QUESTION WAS SHARPENED AND PASSED ALL STERILMED INSPECTION CRITERIA. IT IS POSSIBLE THIS MALFUNCTION MAY RESULT WHEN EXCESSIVE FORCE OR TORQUE IS APPLIED TO THE BLADE DURING USE.

    Description of Event or Problem · 1

    A REPROCESSED STERNUM SAW BLADE BROKE INTO 2 PIECES DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPROCESSED STRYKER STERNUM SAW BLADE REPROCESSED SAW BLADE DZH STERILMED, INC. 298-97-100

    Patients

    Seq Age Sex Outcome Treatment
    1 YR