BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 6737123 · Received July 24, 2017

    Report

    Report Number
    1045254-2017-00252
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Date of Event
    June 29, 2017
    Report Date
    June 29, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    20681490047467
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO OPENED SAMPLES OF PART NUMBER 1884005, FROM LOT NUMBER 0210269571 WERE RECEIVED. SAMPLE 1: VISUALLY, THE INNER TIP BROKE OFF AT THE FIRST PROXIMAL VALLEY WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PORTION THAT BROKE OFF MEASURED 0.22¿. THERE WAS WEAR ON THE INNER SHAFT 0.55¿ FROM THE DISTAL FACE OF THE INNER HUB WHICH MAY INDICATE AGGRESSIVE USE. THE SHAPE OF THE FRACTURE IS CONSISTENT WITH THE BREAKAGE OCCURRING WHILE MOVING IN A CLOCKWISE DIRECTION. SAMPLE 2: VISUALLY, THE INNER TIP WAS FRACTURED APPROXIMATELY HALF WAY THROUGH AT THE FIRST PROXIMAL VALLEY WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THERE WERE NO FRAGMENTS THAT DETACHED. THE SHAPE OF THE FRACTURE IS CONSISTENT WITH THE BREAKAGE OCCURRING WHILE MOVING IN A CLOCKWISE DIRECTION. THE INFORMATION MOST LIKELY INDICATES THE BLADES WERE USE IN CONFLICT WITH THE INSTRUCTIONS FOR USE AND / OR LABELED INDICATIONS. THE MAXIMUM RECOMMENDED SPEED FOR THIS DEVICE IS 5000 RPM IN OSCILLATE MODE / DIRECTION. THE IFU WARNS: DO NOT USE BURS ABOVE THE SPEED INDICATED ON THE BUR LABEL. FOR HIGH SPEED DRILLING (GREATER THAN 6,000 RPM) ENSURE THAT AN XPS HIGH SPEED BUR IS USED; BENDING OR PRYING MAY BREAK THE BLADE OR BUR; AND EXCESSIVE PRESSURE APPLIED TO BUR / BLADE MAY CAUSE BUR FRACTURE. 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

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

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE HEAD OF TWO BLADES FRACTURED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT TIP OF THE BLADES BROKE. THIS BREAK DID RESULT IN FRAGMENTS INSIDE THE PATIENT. THE DOCTOR REMOVED THE FRAGMENTS FROM THE PATIENT WITHOUT ANY MEDICAL INTERVENTION. ANOTHER BLADE (PRODUCT # 1884004) WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516802 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884005 0210269571 20681490047467

    Patients

    Seq Age Sex Outcome Treatment
    1