BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® BLADE

    MDR report key: 5369750 · Received January 15, 2016

    Report

    Report Number
    1045254-2016-00015
    Event Type
    Injury
    Date Received
    January 15, 2016
    Date of Event
    December 23, 2015
    Report Date
    December 23, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION (DETAILED AS FOLLOWS): ANALYSIS FOUND VISUALLY THE TIP OF THE INNER BLADE WAS BROKEN OFF AND THE TIP WERE NOT RETURNED BUT WOULD HAVE MEASURED APPROXIMATELY 0.17¿ TO 0.18¿ LONG. THE BREAK POINT CORRESPONDS TO THE FIRST PROXIMAL VALLEY OF THE INNER BLADE TEETH AND WHEN VIEWED UNDER MAGNIFICATION, THERE WAS LOCKING AREA DEFORMATION ON THE FRONT HUB THAT IS CONSISTENT WITH EXCESS PRESSURE BEING APPLIED WHILE IN THE HANDPIECE. THERE WERE STRIATIONS AROUND THE OUTSIDE DIAMETER OF THE INNER SHAFT 5/8¿ FROM THE DISTAL FACE OF THE INNER HUB WHICH CORRESPONDS TO THE PROXIMAL END OF THE OUTER TUBE IN THE FRONT HUB. THE INFORMATION INDICATES EXCESS PRESSURE WAS APPLIED DURING USE, CAUSING THE DEFORMATION OF THE LOCKING AREA¿WHICH THEN CAUSED THE INNER SHAFTS AND OUTER TUBES TO RUB TOGETHER. THE DEFORMATION OF THE BREAK IS CONSISTENT WITH THE INNER TIP CONTACTING THE OUTER TIP DURING USE. FOR THESE BREAKS TO OCCUR, THE TIPS WOULD HAVE TO BE DEFORMED OR BECOME DEFORMED AND/OR COME IN CONTACT WITH AN UNAPPROVED MATERIAL. INSTRUCTIONS FOR USE WARN THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION]. BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A 4MM ROTATABLE M4 SILVER BULLET BLADE WITH IRRIGATION DURING A ROUTINE SINUS SURGERY ON A (B)(6) MALE WEIGHING 114.5 KG..."A PIECE OF THE INTERNAL CUTTING JAW BROKE AWAY FROM THE SHAFT OF THE BLADE AND DISAPPEARED IN THE PATIENTS ANATOMY, "WHICH THE SURGEON BELIEVES HAPPENED IN THE AREA OF THE LEFT MAXILLARY OSTIUM. A STANDARD 4.0 QUADCUT BLADE WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY... HOWEVER, ABOUT 30 MINUTES WAS SPENT SEARCHING FOR THE MISSING PIECE USING FLEXIBLE SCOPE EQUIPMENT BROUGHT OVER FROM ANOTHER FACILITY, ALONG WITH PERFORMING "COPIOUS EXPLORATION". FURTHERMORE, AFTER THE PATIENT AWOKE FROM SURGERY, HE WAS TAKEN TO AN ENT CLINIC FOR A HEAD CT TO CONFIRM THAT THE BROKEN PIECE IS NOT IN HIS ANATOMY. SEARCH FOR THE BROKEN TIP WAS UNSUCCESSFUL, THE MISSING PIECE WAS NOT SHOWN ON THE CT AND THE PATIENT WAS REPORTED AS "RECOVERING NORMALLY". THERE WAS NO REPORT OF PERMANENT PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28717 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884005HRE 0209766087

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention