BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® BLADE

    MDR report key: 5244180 · Received November 23, 2015

    Report

    Report Number
    1045254-2015-00384
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    October 21, 2015
    Report Date
    October 29, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AT THE MEDTRONIC (B)(4) AND FORWARDED TO MEDTRONIC XOMED. HOWEVER, IT HAS NOT YET BEEN RECEIVED BY MEDTRONIC XOMED. THEREFORE, THE PRODUCT ANALYSIS HAS NOT YET BEEN PERFORMED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE BLADE WAS BEING USED IN REVERSE MODE AT 5000 RPM TO REMOVE SOFT TISSUE TUMORS. THE ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 22, 2016.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS WAS COMPLETED ON NOVEMBER 30, 2015. THE PRODUCT ANALYSIS INDICATES THAT THERE WERE 2 UN-SEALED SAMPLES, PART NUMBER 1884005, FROM LOT NUMBER 0209773942 RECEIVED. THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS ON 1 OF THE 2 SAMPLES, BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE. THE INNER DISTAL TIP WAS BROKEN OFF OF BOTH SAMPLES, WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE TIP WAS RETURNED FOR SAMPLE 1 AND IT MEASURED 0.22¿ IN LENGTH. BASED OFF OF THE DEFORMATION AT THE BREAK, THE INNER BLADE WAS MOVING IN A CLOCKWISE DIRECTION AND THE FIRST PROXIMAL TOOTH IMPACTED THE FIRST PROXIMAL VALLEY ON THE OUTER TUBE WHICH RESULTED IN THE TIP LIFTING OUT OF THE OUTER TUBE AND BREAKING OFF. THE PORTION THAT BECAME DETACHED ON SAMPLE 2 WOULD HAVE MEASURED APPROXIMATELY 0.20¿ AND WAS NOT RETURNED. THE INNER SHAFT OF SAMPLE 1 WAS GOUGED 0.6¿ FROM THE DISTAL FACE OF THE INNER HUB, WHICH CORRESPONDS TO THE PROXIMAL END OF THE OUTER TUBE IN THE FRONT HUB, INDICATING METAL ON METAL CONTACT / CHAFING. THERE WAS ADDITIONAL GOUGING OF THE INNER SHAFT ON BOTH SAMPLES JUST PROXIMAL TO THE BREAK POINT OF THE TIP. THE INSTRUCTIONS FOR USE WARN THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE AND THAT THE DEVICE IS USED FOR THE RESECTION OF SOFT TISSUE AND BONE (EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION). ALTHOUGH THIS CANNOT BE CONFIRMED, THE INFORMATION MAY ALSO INDICATE THE DIRECTION AND/OR SPEED USED WAS INAPPROPRIATE FOR THIS BLADE (BASED OFF OF THE EXTENT OF GOUGING). THE INSTRUCTIONS FOR USE WARN THAT FOR DRILLING AT SPEEDS GREATER THAN 6,000 RPM, AN XPS HIGH SPEED ¿BUR¿ IS TO BE USED.(B)(4).

    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 SKULL BASE TUMOR SURGERY, THE TIP OF THE BLADE BROKE OFF. INITIALLY THE BLADE WORKED, BUT FURTHER INTO THE PROCEDURE THE BLADE WOULD NOT CUT. IT WAS THEN THAT THE USER REALIZED THE TIP OF THE BLADE HAD BROKEN OFF. AFTER A CT CHECK/SCAN, IT WAS CONFIRMED THAT THERE WAS NO FRAGMENT IN THE PATIENT'S BODY. THE SURGERY WAS DELAYED DUE TO THE TIME IT TOOK TO FIND THE FRAGMENT AND HAVE THE CT CHECK/SCAN. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE BLADE WAS BEING USED IN REVERSE MODE AT 5000 RPM TO REMOVE SOFT TISSUE TUMOR(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773080 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884005 0209773942

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention