BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR

    MDR report key: 6399503 · Received March 13, 2017

    Report

    Report Number
    1045254-2017-00082
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Date of Event
    February 16, 2017
    Report Date
    February 16, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: 3334800: DRILL 3334800 VISAO 80K HANDPIECE, S/N (B)(4), LOT 205588485 UDI: (B)(4), 510K: K011321 MANUFACTURED 12/8/2011. PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE BUR ((B)(4)) WAS RECEIVED FOR ANALYSIS. VISUALLY, THE ROUND DIAMOND TIP WITH A PORTION OF THE SHAFT BROKE OFF WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PORTION THAT BROKE OFF MEASURED 0.13¿ IN OVERALL LENGTH. THE CONFIGURATION OF THE FRACTURED SURFACE (SHAFT) IS CONSISTENT WITH A SHEER OR BENDING STRESS. THE CUSTOMER INDICATED THE BREAK OCCURRED DURING USE. THE IFU WARNS THAT EXCESSIVE PRESSURE APPLIED TO BUR MAY CAUSE BUR FRACTURE, AND BENDING OR PRYING MAY BREAK THE BLADE OR BUR. THERE WERE WEAR MARKS ON THE SHAFT SURROUNDING THE BREAK AND CORRESPONDING WEAR TO THE INSIDE DIAMETER OF THE OUTER TUBE WHICH IS CONSISTENT WITH AGGRESSIVE USE. THE INFORMATION MOST LIKELY INDICATES THE BUR WAS SUBJECTED TO AGGRESSIVE USE WHICH RESULTED IN EXCESS WEAR AND SHAFT BREAKAGE. INSUFFICIENT IRRIGATION MAY HAVE ALSO CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDONASAL SKULL BASE SURGERY, ¿WHILE THE CURVED BUR WAS USED, THE BUR TIP WAS BROKEN AND DROPPED IN THE SPHENOIDAL SINUS." AN C-ARM X-RAY WAS TAKEN; "THE TIP/FRAGMENT OF THE BUR COULD BE SEEN IN THE IMAGE, THE TIP/FRAGMENT WAS RETRIEVED BASED ON THE IMAGE BY USING FORCEPS UNDER THE MICROSCOPE." IT WAS CONFIRMED THAT ¿THE BROKEN BUR TIP WAS SUCCESSFULLY REMOVED FROM THE SPHENOIDAL SINUS.¿ THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180920 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 311920115E 0211679687

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention