BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA SAWBLADE

    MDR report key: 7967047 · Received October 15, 2018

    Report

    Report Number
    2025102-2018-00009
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Report Date
    October 15, 2018
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFA
    PMA / PMN Number
    K863788
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SAWBLADE AND BROKEN PIECES WERE EVALUATED. IT APPEARED THAT THE BLADE WAS INSERTED PAST THE HANDPIECE HUB COMPONENT'S CENTRAL BOSS DIAMETER. THIS DAMAGED THE SAWBLADE AND PREVENTED IT FROM LOCKING DOWN AND SPLINTERED THE HUB. THIS ALSO WOULD PREVENT THE BLADE FROM WORKING. AN EXAMINATION OF THE BLADE TEETH ON THE RETURNED SAW FOUND ALL TEETH INTACT WITH NO DAMAGE.

    Description of Event or Problem · 1

    THE BLADE WAS BEING USED DURING A PODIATRY PROCEDURE AND IT STOPPED WORKING WHEN PRESSURE WAS APPLIED TO THE BONE. THE BLADE BROKE AT THE HUB OF THE BLADE. THE DOCTOR REMOVED THE METAL FRAGMENTS AND CONTINUED THE CASE WITH A NEW BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805724 BRASSELER USA SAWBLADE SMALL BONE SAGITTAL SAW BLADE GFA BRASSELER U.S.A. MEDICAL, LLC KM-3101 NQ4NH

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR