BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADCUT STRAIGHTSHOT

    MDR report key: 2994002 · Received March 1, 2013

    Report

    Report Number
    2994002
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    METAL PORTION BROKE DURING THE PROCEDURE UNDER NORMAL USE. QUESTION IF IT MAY HAVE BEEN CRACKED PRIOR TO USE. NO PATIENT HARM OR CHANGE IN PLAN OF CARE. NO ADVERSE EFFECTS ON PATIENT OR BLOOD LOSS. PROCEDURE COMPLETED AS PLANNED.======================MANUFACTURER RESPONSE FOR MICRODEBRIDING ROTATING BLADE, QUADCUT BLADE, 4.3 MM (PER SITE REPORTER).======================WE PLAN TO RETURN TO THEM FOR EVALUATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT AND RIGHT SPHENOETHMOIDECTOMY WITH REMOVAL OF POLYPS; LEFT AND RIGHT MAXILLARY ANTROSTOMY WITH REMOVAL OF POLYPS FOR CHRONIC POLYPOID RHINOSINUSITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89376 QUADCUT STRAIGHTSHOT BLADE, BURR HTT MEDTRONIC XOMED, INC * 0206266062

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR DURING SURGERY