BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS, INC. (INCLUDED IN CUSTOMED KIT)

    MDR report key: 835010 · Received February 13, 2007

    Report

    Report Number
    2648727-2007-00001
    Event Type
    Malfunction
    Date Received
    February 13, 2007
    Date of Event
    January 22, 2007
    Report Date
    February 13, 2007
    Manufacturer
    AMERICAN MEDICAL SPECIALTIES, INC.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMED RECEIVES FINISHED PACKAGED STERNUM SAW BLADE FROM AMS, INC. AND INCLUDES IN ONE CUSTOMER PACK, CAT. NO. 900-170, FOR CARDIOVASCULAR SURGERY. STRYKER-TYPE STERNUM SAW BLADE LOT #051104G WAS INCLUDED IN 900-170 LOT #106102159 MANUFACTURED IN OCTOBER/2006. THIS BLADE IS DESIGNED TO BE USED IN SYSTEM V EQUIPMENT, BUT HOSPITAL ELECTRICAL EQUIPMENT WASN'T AVAILABLE, SO THEY USED SYSTEM II EQUIPMENT, WHICH ALTHOUGH SHOULD FIT IS MUCH OLDER. THE SYSTEM II HAS BEEN SENT TO BIOMEDICAL LAB FOR CHECKING. CUSTOMED HAS SENT ONE SAMPLE OF AFFECTED BLADES TO AMERICAN MEDICAL SPECIALTIES FOR EVALUATION. MANUFACTURER CONFIRMS THAT BLADE MEETS SPECIFICATIONS AND HOSPITAL CONFIRMS THAT INCIDENT ONLY OCCURRED WHEN USING OLDER PNEUMATIC EQUIPMENT.

    Description of Event or Problem · 1

    STERNUM BLADE NOT STAY FORMALLY ATTACH TO SAW DURING SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS, INC. (INCLUDED IN CUSTOMED KIT) STRYKER-TYPE STERNUM SAW BLADE GFA AMERICAN MEDICAL SPECIALTIES, INC. NA 051104G

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR