BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE 1882040 5PK INFERIOR TURB 2MM

    MDR report key: 1901026 · Received November 17, 2010

    Report

    Report Number
    1045254-2010-00058
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. CLARIFICATION TO: "DATE OF EVENT". A FACILITY REPRESENTATIVE STATED ON (B)(4) 2010 THAT THE EVENT OCCURRED "ABOUT A MONTH AGO." WHILE IT IS NOT UNCOMMON FOR A POWERED BLADE TO BREAK DURING USE, OUR DATA SHOWS THAT ON RARE OCCASION, A SERIOUS INJURY (SI) OR ADDITIONAL MEDICAL INTERVENTION MAY BE REQUIRED, DUE TO A BLADE BREAK RESULTING IN A DEVICE FRAGMENT. IN MOST CASES, BLADE FRAGMENTS ARE EASILY REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION OR HARM TO THE PATIENT AND THE SURGERY PROCEEDS AS PLANNED. FDA GUIDANCE DECLARES THAT IF A MALFUNCTION HAS CAUSED A DEATH OR SI EVEN ONCE, THEN IT MEANS IT IS "LIKELY" TO RECUR. GIVEN THIS GUIDANCE AND OUR EXPERIENCE WITH BLADE BREAKS, ANY BLADE BREAK RESULTING IN A DEVICE FRAGMENT IS SUBMITTED AS A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING A PROCEDURE, THE TIP OF THE BLADE BROKE OFF. THE BLADE TIP WAS REMOVED FROM THE SURGICAL SITE WITHOUT THE USE OF ADDITIONAL EQUIPMENT OR MEDICAL PROCEDURES. THERE WAS NO ADVERSE PATIENT CONSEQUENCES OR SEQUELLA REPORTED. ALL PORTIONS OF THE BROKEN BLADE WERE RETURNED, INDICATING THAT NO UNRETRIEVED DEVICE FRAGMENTS WERE LEFT IN THE PATIENT. THE TIP THAT SEPARATED FROM THE SHAFT MEASURED APPROXIMATELY 1/8 INCH. THE TIP HAD GOUGES ON THE CUTTING FACE WITH CORRESPONDING MARKS ON THE OUTER TUBE INDICATING THAT THE TIP MAY HAVE COME IN CONTACT WITH AN INAPPROPRIATE MATERIAL. VISUAL INSPECTION OF THE OUTER TUBE SHOWED A PORTION OF THE MOUTH OPENING WAS PUSHED INWARD. INDENTATIONS AND MARKS ON THE INNER BLADE INDICATED THE INNER CAUGHT THE OUTER. FUNCTIONAL INSPECTION CONFIRMS THAT THE BLADE LOADS PROPERLY INTO THE HANDPIECE. NO OTHER DAMAGE OR DEFECT WAS FOUND. INSTRUCTIONS FOR USE STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO: SHOULD A BLADE FRACTURE OCCUR DURING USE, EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS OF THE BLADE ARE RETRIEVED AND REMOVED FROM THE PATIENT. UNREMOVED BLADE FRAGMENTS MAY CAUSE TISSUE DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE 1882040 5PK INFERIOR TURB 2MM BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1882040 H7683022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention