BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 1882960 5PK PEDIATRIC RND 2.9MM

    MDR report key: 2950746 · Received February 8, 2013

    Report

    Report Number
    1045254-2013-00083
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). RESULT: STRESS PROBLEM. A TOTAL OF TWO OUTER TUBES AND ONE INNER TUBE WERE RETURNED FOR EVALUATION. THEY WERE RETURNED WITHOUT THE ORIGINAL POUCH AND PRODUCT LABEL. THE RETURNED DEVICE APPEARED TO BE A BUR DEVICE AND BASED ON THE CONDITION, APPEARED TO HAVE BEEN USED. UPON OBSERVATION, THE INNER TUBE WAS FOUND REMOVED FROM THE OUTER TUBE. THE FIRST OUTER TUBE APPEARED FREE OF DAMAGE. THE SECOND TUBE APPEARED TO HAVE MINOR MARKINGS AND DISCOLORATION ON THE SHAFT INDICATING CUSTOMER USE. THE OUTER TUBE HUB WAS FOUND DAMAGED AS IT APPEARED THAT SOME PORTION OF INNER HUB HAD MELTED / GRINDED ONTO THE SURFACE OF THE OUTER HUB AND WAS CLEARLY VISIBLE. THIS IS INDICATIVE OF LONG RUN TIME AT POSSIBLE HIGHER SPEEDS AND EXCESSIVE APPLICATION OF FORCE BY THE CUSTOMER. THE INNER TUBE SHAFT WAS OBSERVED AND WAS FOUND BROKEN AT THE EDGE OF THE RAMP NEAR THE PROXIMAL END. THE BUR TIP WAS FOUND INTACT ON THE BROKEN SHAFT PIECE. THE WELDED BUR TIP ITSELF DID NOT DETACH FROM THE INNER TUBE COMPONENT. THE INNER TUBE SHAFT REVEALED OBVIOUS INDENTATIONS / MARKINGS AND DISCOLORATION CLOSE TO THE BREAKAGE POINT AT PROXIMAL END. THIS IS INDICATIVE OF SEVERE USE OF THE DEVICE AND APPLICATION OF EXCESSIVE FORCE BY THE CUSTOMER LEADING TO AN INADVERTENT BREAKAGE OF THE TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BURRS BROKE DURING A CRANIOTOMY PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT 2 BURRS BROKE DURING A CRANIOTOMY PROCEDURE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BURS WERE USED WITH AN M4 ON A HEAVY BONE INSIDE THE NOSE. THEY REPORTED THAT THEY WERE UNABLE TO LOCATE A PIECE OF THE BUR, BUT THERE WAS NO REPORT OF PATIENT IMPACT. THE FACILITY BELIEVES THE BURS BROKE BECAUSE IT WAS TOO HEAVY OF DRILLING FOR THE BUR. THEY DO NOT BELIEVE IT WAS A DEFECT WITH THE BURS. THEY SWITCHED TO A NEURO DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54771 BUR 1882960 5PK PEDIATRIC RND 2.9MM BUR, EAR, NOSE AND THROAT EQJ XOMED MFG JACKSONVILLE 1882960 0205958596

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR