BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 1882960 5PK PEDIATRIC RND 2.9MM

    MDR report key: 3708799 · Received March 28, 2014

    Report

    Report Number
    1045254-2014-00069
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 27, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BUR WAS RETURNED AND ANALYZED BY THE QUALITY ENGINEERING TEAM. RECEIVED ONE (1) SAMPLE(S) WITH ORIGINAL OPENED POUCH AND LABEL IDENTIFYING PART #1882960 [PEDIATRIC ROUND BUR 2.9MM] FROM LOT #63570300. THE CONDITION OF THE DEVICE SHOWED CUSTOMER USE AS THERE WAS PRESENCE OF CONTAMINANTS ON THE OUTER SHAFT. FROM VISUAL EVALUATION, THE INNER SHAFT WAS FOUND BROKEN NEAR THE DISTAL TIP. THE BROKEN TIP ASSEMBLY MEASURED APPROXIMATELY 10MM. UPON VISUAL EVALUATION, THE BUR TIP APPEARED TO HAVE SOME LEVEL OF VISIBLE DAMAGE (CHIPPING) WHICH IS POSSIBLY INDICATIVE OF PROCEDURAL / ANATOMICAL / OPERATIONAL CONTEXT FACTORS ENCOUNTERED BY THE CUSTOMER DURING PROCEDURE WHICH MAY INCLUDE AND ARE NOT LIMITED TO DIFFICULT ANATOMICAL LOCATION, HARD BONE/TISSUE STRUCTURE. THESE FACTORS CAN CAUSE THE CUSTOMER TO EXERT PRESSURE, MANIPULATE AND/OR MANEUVER THE DEVICE IN AN AGGRESSIVE MANNER THAT MAY LEAD TO TIP BREAKAGE. THE REPORTED COMPLAINT IS CONFIRMED FOR "BUR HEAD SHEARED OFF". THE MOST LIKELY ROOT CAUSE IS OPERATIONAL CONTEXT WHERE EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE BUR TIP DURING USE. METHOD - MICROSCOPIC INSPECTION. RESULTS - STRESS PROBLEM; DEFORMATION PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE FOR UNILATERAL CHOANAL ATRESIA AT THE BEGINNING OF THE CASE AFTER DRILLING HAD JUST STARTED THE BUR HEAD SHEARED OFF. THE BUR TIP WAS RETRIEVED AND SURGERY CONTINUE WITH ANOTHER BUR. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184406 BUR 1882960 5PK PEDIATRIC RND 2.9MM BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1882960 63570300

    Patients

    Seq Age Sex Outcome Treatment
    1 00006 YR