BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED BUR

    MDR report key: 4135306 · Received October 2, 2014

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    Report

    Report Number
    1045254-2014-00238
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1883673HS, CHOANAL ATRESIA TAPER BUR; MANUFACTURE DATE ¿ MAY 20, 2009; LOT ¿ 47407500; USE BEFORE DATE ¿ NOVEMBER 2, 2014. (B)(4). THE DEVICES HAVE NOT BEEN RETURNED YET. THEREFORE, AN ANALYSIS CANNOT BE PERFORMED AT THIS TIME. METHOD CODE: NO TESTING METHODS PERFORMED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT ANALYSIS INDICATES THAT THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. WHEN COMPARED TO THE ASSEMBLY DRAWING 66500041 REVISION B, THE INNER TUBE WAS SHEARED THROUGH AT A LOCATION CORRESPONDING WITH THE PROXIMAL END OF THE OUTER TUBE INDICATING EXCESSIVE SIDE LOADING OF THE DEVICE. THE INSTRUCTIONS FOR USE, 68E3858 REVISION E, WARNS THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION]. BASED ON THE ABOVE OBSERVATIONS, THE UNDERLYING CAUSE IS CONSISTENT WITH MISUSE/USER ERROR. 1883673HS: THE PRODUCT ANALYSIS INDICATES THAT THE SAMPLE WAS RECEIVED WITH THE ORIGINAL OPENED POUCH AND LABELS. THE CONDITION OF THE DEVICE SHOWED CUSTOMER USE AS THERE WAS PRESENCE OF CONTAMINANTS ON THE BUR HEAD. FROM VISUAL EVALUATION, THE SPIRAL WRAP WAS FOUND BROKEN NEAR THE TIP. THE SPIRAL WRAP HYPEREXTENSION, UNRAVELING, OR BREAKING IS INDICATIVE OF POSSIBLE PROCEDURAL, ANATOMICAL, AND/OR OPERATIONAL FACTORS ENCOUNTERED BY THE CUSTOMER DURING THE PROCEDURE WHICH MAY HAVE LED TO THE FAILURE OBSERVED ON THE DEVICE. THESE FACTORS INCLUDE AND ARE NOT LIMITED TO DIFFICULT ANATOMICAL LOCATION AND/OR HARD BONE/TISSUE STRUCTURE. THESE FACTORS CAN CAUSE THE CUSTOMER TO EXERT PRESSURE, MANIPULATE AND/OR MANEUVER THE DEVICE IN A MANNER THAT MAY LEAD TO HYPEREXTENSION OR BREAKAGE OF THE SPIRAL WRAP ASSEMBLY. THE MOST LIKELY UNDERLYING CAUSE IS RELATED WITH 'OPERATIONAL CONTEXT' AS IT IS POSSIBLE THAT MANEUVERING OF THE DEVICE DUE TO PROCEDURAL, ANATOMICAL, AND/OR OPERATIONAL FACTORS ENCOUNTERED DURING THE PROCEDURE MAY HAVE LED TO THE FAILURE. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC CHOANAL ATRESIA REPAIR, TWO BURS KEPT JAMMING WITH PIECES OF BONE. AFTER THEY WERE CLEANED SEVERAL TIMES, THE SHAFT BROKE AWAY FROM THE HANDPIECE AND INTO THE PATIENT. THE USER WAS ABLE TO RETRIEVE THE PIECE THAT BROKE OFF OF EACH BUR AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615852 CURVED BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1882969 0205884344

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR