BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® BLADE

    MDR report key: 4939669 · Received July 24, 2015

    Report

    Report Number
    1045254-2015-00249
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 30, 2015
    Report Date
    June 30, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: 1895400: FOOTSWITCH 1895400 XPS, S/N (B)(4), LOT 35328200 MANUFACTURED: 09/15/2004. 1897102: CONSOLE 1897102 XPS 3000 2 PUMP, S/N (B)(4), LOT 35127100 MANUFACTURED: 08/30/2004. 1898200T: MICRODEBRIDER 1898200T IGS M4, S/N (B)(4), MANUFACTURED: 04/03/2008 (B)(4). PRODUCT EVALUATION: -- DRILL 1882900 MINI TREPHINATION 2MM: NO ANALYSIS RESULTS AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION. -- FOOTSWITCH 1895400 XPS: SERVICE AND REPAIR FOUND THAT THE CABLE IS KINKED, THE PUSHBUTTON IS DAMAGED AND DOES NOT WORK, THE DECAL IS DAMAGED AND THE FOOT PLATE IS BENT WHICH DOES NOT ALLOW MAXIMUM SPEED TO BE REACHED. THE FOOT PLATE WAS CORRECTED, SCREW UPDATE WAS PERFORMED, DECALS WERE REPLACED AND THE CABLE WAS REPLACED. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. -- CONSOLE 1897102 XPS 3000 2 PUMP: SERVICE AND REPAIR FOUND THAT THE DISPLAY SCREEN OVERLAY IS SCRATCHED AND THE BEZEL IS DAMAGED. THE BEZEL AND OVERLAY HAVE BEEN REPLACED. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. -- MICRODEBRIDER 1898200T IGS M4: NO ANALYSIS RESULTS AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT STATES: ¿THEY DID RUN THE DRILL AT 12000RPM AND ARE AWARE IT SHOULD ONLY BE 6000RMP BUT SAY THEY ALWAYS RUN AT 12000RMP AND HAVE NOT HAD AN ISSUE BEFORE.¿ IT HAS BEEN CONFIRMED THAT THE OUTER LABEL OF THE DEVICE STATES THAT THE MAXIMUM SPEED THIS DEVICE CAN TO BE RUN IS <(><<)>6000RPM. DATE OF THIS REPORT: 06/30/2015. DEVICE AVAILABLE FOR EVALUATION? YES RETURN DATE: 08/11/2015. DATE RECEIVED BY MANUFACTURER: 08/13/2015. PRODUCT EVALUATION: -- DRILL (B)(4) MINI TREPHINATION 2MM: WHEN RECEIVED FOR ANALYSIS, THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS ON ONE SAMPLE [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. THE SAMPLES WERE ANALYZED. TWO OF THE SAMPLES HAD BROKEN DRILL BIT SHAFTS. THE SHAFTS WERE FRACTURED AT THE LOCATION WHERE THE DRILL BIT EXITS THE OUTER PIECE OF THE ASSEMBLY. NO MATERIAL OR MANUFACTURING DEFECTS WERE FOUND. THE THIRD SAMPLE WAS NOT BROKEN BUT THE CUSTOMER CLAIMED THAT THIS SAMPLE DID NOT CUT BONE. ALL SAMPLES CONFORMED TO DRAWINGS INCLUDING THE CUTTING FLUTES. THE ALLEGED MALFUNCTION [NOT CUTTING] COULD NOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 DRILL BITS WERE USED IN A PROCEDURE TO REMOVE A FRONTAL MUCOELE. TWO OF THE BITS SNAPPED WHILE CONNECTED TO THE M4 HAND PIECE AND BEING TESTED RUNNING AT 12000RPM (RECOMMENDED 6000RPM), PRIOR TO PATIENT INVOLVEMENT. IT WAS CONFIRMED THAT NO FRAGMENTS WERE IN CONTACT WITH THE STERILE FIELD; THESE WERE BEING TESTED AWAY FROM THE PATIENT. THE THIRD DRILL BIT DID NOT SNAP, BUT DID NOT PENETRATE THE BONE FOR WHICH IT IS DESIGNED. THIS WAS WHILE RUNNING AT 6000RPM. THEY SUBSEQUENTLY INCREASED THE POWER TO 12000RPM BUT STILL THE DRILL DID NOT TAKE TO THE BONE. THE PROCEDURE WAS NOT FULLY COMPLETED AND A COMPLETION WILL MOST LIKELY BE SCHEDULED FOR A LATER DATE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482704 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1882900 0209138675

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention