BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 1884562HS 3PK AGGRESSIVE ROUTER 4.5M

    MDR report key: 3802392 · Received May 9, 2014

    Report

    Report Number
    1045254-2014-00103
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE HAS BEEN RECEIVED; PRODUCT EVALUATION IS CURRENTLY UNDERWAY. METHOD - NO TESTING METHODS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED BY THE QUALITY ENGINEERING TEAM. AS RECEIVED CONDITION: RECEIVED ONE (1) SAMPLE WITH ORIGINAL PRODUCT POUCH AND LABEL IDENTIFYING SAMPLE AS (B)(4) FROM LOT NUMBER 0205612850. BASED ON THE CONDITION OF THE DEVICE, CUSTOMER USE WAS VISIBLE. UPON OBSERVATION, THE INNER TUBE WAS FOUND REMOVED FROM THE OUTER SHAFT. THE INNER SHAFT WAS FOUND BROKEN AT THE EDGE OF THE RAMP NEAR THE PROXIMAL END, CAUSING SEPARATION OF THE BUR HEAD FROM THE SHAFT. IT SHOULD BE NOTED THAT THE BUR HEAD ITSELF DID NOT DETACH FROM THE INNER SHAFT ASSEMBLY. IT WAS ONLY DUE TO THE FRACTURING OF THE INNER SHAFT NEAR THE TIP THAT CAUSED THE BUR HEAD TO SEPARATE FROM THE ASSEMBLY. THE INNER TUBE SHAFT REVEALED OBVIOUS INDENTATIONS/MARKINGS AND DISCOLORATION CLOSE TO THE BREAKAGE POINT AND NEAR THE PROXIMAL END CLOSE TO THE HUB. THIS IS INDICATIVE OF AGGRESSIVE USE OF THE DEVICE AND APPLICATION OF EXCESSIVE FORCE BY THE CUSTOMER LEADING TO AN INADVERTENT BREAKAGE OF THE TIP. NO VISIBLE DAMAGES WERE NOTICED TO THE BROKEN BUR HEAD COMPONENT. IN CONCLUSION, THE REPORTED COMPLAINT WAS CONFIRMED [BROKEN BUR]. (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 "THE TIP BROKE OFF IN THE SPHENOID SINUS DURING DRILLING. THE PIECE WAS RETRIEVED AND NO INJURY APPARENT TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281922 BUR 1884562HS 3PK AGGRESSIVE ROUTER 4.5M BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884562HS 0205612850

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR