BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR - IPC® M5 AND M4 30K

    MDR report key: 6054994 · Received October 25, 2016

    Report

    Report Number
    1045254-2016-00360
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1885061HS ¿ ROUND DIAMOND 5MM 15DE BUR; LOT NUMBER ¿ 0210649448; MANUFACTURE DATE ¿ JANUARY 8, 2016; USE BEFORE DATE ¿ JANUARY 6, 2024; 510K ¿ EXEMPT. THE TWO HIGH SPEED BURS HAVE NOT BEEN RETURNED. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MODEL #: 1884070RTC CATALOG #: 1884070RTC. DEVICE AVAILABLE FOR EVALUATION?: YES RETURN DATE: NOVEMBER 16, 2016. DATE MANUFACTURER RECEIVED: NOVEMBER 16, 2016. (B)(4): THE PRODUCT ANALYSIS INDICATES THAT THE PRODUCT WAS RECEIVED WITH PAPERWORK (INCLUDING FINISHED GOODS POUCH) AND MARKED ON THE PACKAGE MATCHING THIS EVENT. HOWEVER, THE PRODUCT RECEIVED DID NOT APPEAR TO BE THE PRODUCT REPORTED. ONE UN-SEALED SAMPLE OF PART NUMBER (B)(4) WAS RECEIVED. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE. THE REPORTED PART NUMBER WAS (B)(4) FROM LOT 0210553188, WHICH WAS ON THE POUCH THE BUR WAS RETURNED IN (THE PART NUMBER WAS SCRATCHED OUT). HOWEVER, BASED OFF OF THE COLOR AND CONFIGURATION, THE BUR IS AN (B)(4). A MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0, 65 TO 5, 0 MAGNIFICATION SETTINGS) AND IPC CONSOLE IN CONJUNCTION WITH AN M4 HANDPIECE WERE USED TO ANALYZE THE BUR. WHEN COMPARED TO THE ASSEMBLY DRAWING, THE INNER ASSEMBLY SPINS FREELY BY HAND, WHICH IS NOT CONSISTENT WITH THE REPORTED COMPLAINT. VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE, WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. FUNCTIONALLY, THE BUR WAS LOADED / LOCKED INTO A HANDPIECE, RAN AT 12,000 RPM, AND CUT SAW BONE WITH NO ISSUES. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING AND THEREFORE HAS BEEN RULED OUT AS A LIKELY CAUSE. THE INFORMATION MOST LIKELY INDICATES EITHER THE BUR WAS NOT LOADED / ENGAGED PROPERLY OR TEMPORARILY SEIZED DUE TO EXCESS AXIAL LOAD. 1885061HS: ONE UN-SEALED SAMPLE OF PART NUMBER 1885061HS FROM LOT NUMBER 0210649448 WAS RECEIVED. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE. A MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0, 65 TO 5, 0 MAGNIFICATION SETTINGS) WAS USED TO ANALYZE THE BUR. WHEN COMPARED TO THE ASSEMBLY DRAWING, VISUALLY, THE SPIRAL WRAP WAS DEFORMED AND THE INNER ASSEMBLY WAS PULLED OUT OF THE SUPPORT AREA, WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THERE WAS NO DETACHMENT OF A COMPONENT (NO DEVICE FRAGMENTS) OBSERVED. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS GOUGING OF THE OUTSIDE DIAMETER OF THE INNER SHAFT JUST PROXIMAL TO THE TIP WITH CORRESPONDING DAMAGE TO THE OUTER TUBE SUPPORT AREA (ALMOST WORN THROUGH ON ONE SIDE). THE SPIRAL WRAP WAS TWISTED IN ON ITSELF IN A CLOCKWISE DIRECTION, WHICH INDICATES A TORSIONAL LOAD BETWEEN THE GOUGED AREA OF THE INNER SHAFT AND THE SPIRAL WRAP DAMAGE. THERE WAS BIOLOGICAL CONTAMINANTS COMPACTED IN THE DIAMOND GRIT TIP, WHICH MAY LEAD TO EXCESS PRESSURE TO MAINTAIN PERFORMANCE. THE INFORMATION MOST LIKELY INDICATES TORSIONAL LOAD FROM USE, COMBINED WITH EXCESS PRESSURE, CAUSED FRICTION, WHICH RESULTED IN THE SUBSEQUENT DAMAGE. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING AND THEREFORE HAS BEEN RULED OUT AS A LIKELY CA USE.

    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 A FRONTAL DRILLOUT FOR PERIORBITAL CELLULITIS FROM FRONTAL SINUSITIS, WHICH CONSISTED OF VERY OSTEITIC BONE, THE SPIRAL WRAP ON TWO HIGH SPEED BURS BROKE DURING INITIAL USE. THERE WERE NO FRAGMENTS AND NO MEDICAL INTERVENTION REQUIRED. A REPLACEMENT BUR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705879 XPS® BUR - IPC® M5 AND M4 30K BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884070RTC 0210553188

    Patients

    Seq Age Sex Outcome Treatment
    1