BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER USA SAW BLADES

    MDR report key: 4758439 · Received May 6, 2015

    Report

    Report Number
    2025102-2015-00001
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Report Date
    May 5, 2015
    Manufacturer
    BRASSELER USA, MEDICAL L.L.C.
    Product Code
    GFA
    PMA / PMN Number
    K863788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP: WITH THE INFORMATION PROVIDED AND NO PRODUCT RETURNED FOR EVALUATION A ROOT CAUSE CANNOT BE DETERMINED. A POSSIBLE CAUSE MAY BE METAL GALLING OR BUILD-UP INSIDE THE CUTTING FIXTURE FROM PRIOR USE.

    Additional Manufacturer Narrative · 1

    NO DEVICE AVAILABLE FOR EVAL. THE HOSPITAL DID NOT SAVE ANY OF THE USED BLADES OR PACKAGING.

    Description of Event or Problem · 1

    SURGEON STATED THAT THERE WERE METAL SHAVINGS LEFT IN THE PT DURING TOTAL KNEE SURGERY. THE HOSPITAL DID NOT SAVE ANY OF THE USED BLADES OR PACKAGING. THERE WERE NO INJURIES, BUT DOCTOR STATED HE WAS NOT CERTAIN IF THERE COULD BE COMPLICATIONS IN THE FUTURE IF ANY METAL WAS STILL IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298372 BRASSELER USA SAW BLADES SUTGICAL SAW BLADE GFA BRASSELER USA, MEDICAL L.L.C.

    Patients

    Seq Age Sex Outcome Treatment
    1