BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZB-136 4MM 7.9MM OVAL CUT BUR SURGICAL CARBIDE LATEX

    MDR report key: 10913714 · Received November 27, 2020

    Report

    Report Number
    10913714
    Event Type
    Malfunction
    Date Received
    November 27, 2020
    Date of Event
    November 10, 2020
    Report Date
    November 18, 2020
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS LLC
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DOCTOR HAD USED THE NEEDLE PASSING BUR FOR THE PROCEDURE AND NOTICED THAT THE TIP HAD BROKEN OFF. XRAY WAS PERFORMED AND THE DOCTOR WAS ABLE TO IDENTIFY THE LOCATION OF THE BROKEN BUR TIP. THE TIP WAS REMOVED AND THE PROCEDURE WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378740 ZB-136 4MM 7.9MM OVAL CUT BUR SURGICAL CARBIDE LATEX BURR, ORTHOPEDIC HTT MICROAIRE SURGICAL INSTRUMENTS LLC 046029 ZB136 +M138ZB-1361$

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA