BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE SAGITTAL SAW BLADE

    MDR report key: 11841605 · Received May 17, 2021

    Report

    Report Number
    MW5101388
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    May 3, 2021
    Report Date
    May 14, 2021
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS LLC
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    SUTURE; SURGEON WAS USING SAGITTAL SAW BLADE TO CUT PROXIMAL TIBIA. BLADE BROKEN. NICKED SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735013 MICROAIRE SAGITTAL SAW BLADE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA MICROAIRE SURGICAL INSTRUMENTS LLC 25-302 0221356869

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other