BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 6945839 · Received October 12, 2017

    Report

    Report Number
    3004209178-2017-21727
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 20, 2017
    Report Date
    February 23, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EQJ
    UDI-DI
    20681490047443
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS INDICATES ONE OPENED AND THREE SEALED SAMPLES OF PART NUMBER 1884002 FROM LOT NUMBER HG1R6BQ WERE RECEIVED. ONLY THE OPENED SAMPLE WAS ANALYZED. A MICROSCOPE AND CALIPERS WERE USED TO EVALUATE THE OPENED SAMPLE. VISUALLY, THE INNER TIP WAS BROKEN OFF AT THE FIRST PROXIMAL TOOTH VALLEY WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PORTION THAT BROKE OFF WAS NOT RETURNED HOWEVER IT WOULD HAVE MEASURED APPROXIMATELY ¼¿. THE MOUTH OPENING WHERE THE CUTTING ACTION IS PERFORMED SHOWED IMPACT MARKS ON THE OUTER CUTTER CONSISTENT WITH THE DAMAGE OCCURRING WHILE THE BLADE WAS MOVING IN A CLOCKWISE DIRECTION. THERE WERE NO SIGNS OF MISUSE OR MISHANDLING. VISUALLY, THERE WERE NO SIGNS OF BENDS IN THE INNER OR OUTER ASSEMBLIES. THERE WAS UNEVEN WEAR INSIDE THE CUTTING TIP WHICH MAY INDICATE AN INTERFERENCE FIT (PROFILE DEVIATION) BETWEEN THE INNER AND OUTER ASSEMBLIES. THERE WAS EVEN WEAR 5/8¿ FROM THE DISTAL FACE OF THE INNER HUB. THE INNER CUTTER AND OUTER TUBE ARE SUPPLIER MANUFACTURED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A BLADE BROKE DURING USE. THERE WAS NO PATIENT IMPACT OR INJURY. THERE CUSTOMER ALSO REPORTED THAT TWO SIMILAR EVENTS OCCURRED PREVIOUSLY. CASE 1 OF 3 WAS FILED UNDER REGULATORY REPORT # 3004209178-2017-20317 (MEDTRONIC INTERNAL REFERENCE NUMBER 702059037). CASE 2 OF 3 WAS FILED UNDER REGULATORY REPORT # 3004209178-2017-20318 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)). THIS REGULATORY REPORT IS BEING FILED FOR CASE 3 OF 3 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724961 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC PUERTO RICO OPERATIONS CO. 1884002 HG1R6BQ 20681490047443

    Patients

    Seq Age Sex Outcome Treatment
    1