BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 6619391 · Received June 7, 2017

    Report

    Report Number
    1045254-2017-00175
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Date of Event
    February 13, 2017
    Report Date
    April 5, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    20681490047443
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED SAMPLE OF PART NUMBER 1884002, FROM LOT NUMBER 0211465327 WAS RETURNED. EVALUATION INDICATED THAT VISUALLY, THE INNER TIP WAS BROKEN WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. CONTRARY TO THE REPORTED EVENT, THE TIP WAS BROKEN ¿OFF¿, NOT ATTACHED, AND NOT RETURNED. THE BREAK POINT WAS AT THE FIRST PROXIMAL VALLEY AND PROCEEDED TO THE SECOND PROXIMAL VALLEY. THE LENGTH OF THE PORTION THAT BROKE OFF WOULD HAVE MEASURED APPROXIMATELY 0.15¿. THE MOUTH OPENING WHERE THE CUTTING ACTION IS PERFORMED SHOWED IMPACT MARKS ON THE OUTER AND INNER CUTTERS CONSISTENT WITH THE DAMAGE OCCURRING WHILE THE BLADE WAS IN FORWARD MOTION. THE FRONT HUB LOCKING AREA WAS DEFORMED AND THE DAMAGE WAS CONSISTENT WITH BEING CAUSED BY THE BACK SIDE OF THE FRONT COLLET OF THE HANDPIECE. THE CUSTOMER INDICATED THE BREAK OCCURRED DURING SURGERY; THIS IN CONJUNCTION WITH THE DEFORMATION OF THE HUB AND TIP BREAK THE INFORMATION MOST LIKELY INDICATES AGGRESSIVE USE SUCH AS EXCESS PRESSURE APPLIED TO THE BLADE DURING USE. THE IFU WARNS THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION]. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INTRAOPERATIVE A BLADE BROKE DURING THE SURGERY. NO FRAGMENT WAS FOUND IN THE PATIENT. THE OPERATION WAS DELAYED FOR LESS THAN 10 MINUTES. ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE TIP BROKE, BUT IS STILL ATTACHED TO THE SHAFT; THERE WERE NO FRAGMENTS. THERE WAS NO PATIENT IMPACT. THE PRODUCT ANALYSIS OF THE DEVICE INDICATES THAT TIP OF THE BLADE BROKE OFF NOT ATTACHED, AND NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398941 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884002 0211465327 20681490047443

    Patients

    Seq Age Sex Outcome Treatment
    1