BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER U.S.A. SURGICAL SAW BLADES

    MDR report key: 5147827 · Received October 9, 2015

    Report

    Report Number
    2025102-2015-00005
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Report Date
    October 9, 2015
    Manufacturer
    BRASSELER USA, MEDICAL L.L.C.
    Product Code
    GFA
    PMA / PMN Number
    K863788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED. UNABLE TO DETERMINE THE CAUSE. BLADE WAS CHATTERING INDICATES THE HANDPIECE DRIVING THE BLADE MAY BE IN NEED OF MAINTENANCE. IF INTERNAL DRIVING COMPONENTS OF THE HANDPIECE ARE WORN THE BLADE MAY NOT FUNCTION AS DESIGNED AND MAY CAUSE PERFORMANCE ISSUES SUCH AS THOSE DESCRIBED IN THIS REPORTED COMPLAINT DETAIL. BECAUSE NO LOT NUMBER WAS PROVIDED, AND NO PRODUCT WAS RETURNED, SHIPMENTS TO THE FACILITY WERE REVIEWED USING THE CUSTOMER ACCOUNT. TWO LOTS OF BLADES WERE SENT TO THE CUSTOMER IN 2015. BOTH OF THE RELATED LOTS ARE WITHIN SPECIFICATION. AFTER ADDITIONAL INQUIRIES WITH THE FACILITY IT WAS COMMUNICATED THAT THE HANDPIECE USED DURING THE CASE IS VERY OLD AND WORN. AFTER THE MANUFACTURER EVALUATED THE HANDPIECE, A NEW HANDPIECE WAS RECOMMENDED.

    Description of Event or Problem · 1

    DOCTOR NOTED THE BLADE WAS CHATTERING SIGNIFICANTLY DURING THE LAST FEW CASES. THE DOCTOR ALSO NOTED THAT HE CUT HIMSELF ON THE BLADE, BUT DID NOT HAVE ANY INFORMATION OR AWARE OF EXACTLY HOW IT HAPPENED. NO BLADES SAVED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671991 BRASSELER U.S.A. SURGICAL SAW BLADES GFA BRASSELER USA, MEDICAL L.L.C. BR1-1990-50-90X19 MM 1.27MM MAT THK/1.27MM CUT THK

    Patients

    Seq Age Sex Outcome Treatment
    1