BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 7774143 · Received August 10, 2018

    Report

    Report Number
    3004209178-2018-17997
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 16, 2018
    Report Date
    October 18, 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
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT ANALYSIS IS NOT AVAILABLE; THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ONE OPENED SAMPLE OF PART NUMBER 1884002, FROM LOT NUMBER HG1YM5X WAS RETURNED FOR ANALYSIS. VISUALLY, THE DISTAL TIP HAD BROKEN OFF THE INNER CUTTER WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT; THE DETACHED PORTION MEASURED APPROXIMATELY 0.24¿ IN LENGTH. THE BREAK OCCURRED AT THE FIRST PROXIMAL TOOTH VALLEY, AND THE ASSEMBLIES WERE DEFORMED IN A WAY THAT INDICATES THE INNER BLADE TEETH IMPACTED THE OUTER CUTTING EDGE AT THE THIRD PROXIMAL TOOTH AND VALLEY WHILE MOVING IN A CLOCKWISE DIRECTION. THERE WAS NO EVIDENCE OF CONCENTRICITY ISSUES OR BENDS IN THE RETURNED TUBE/SHAFT ASSEMBLIES. THERE WAS NO EVIDENCE OF MISUSE OR MISHANDLING, AND THERE WAS UNEVEN WEAR AT THE CUTTING TIP WHICH MAY INDICATE AN INTERFERENCE FIT BETWEEN THE INNER AND OUTER ASSEMBLIES AT THE TIP. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TIP OF THE BLADE BROKE WITHIN 30 SECONDS OF USE DURING A FESS PROCEDURE. NO FRAGMENTS REMAINED IN THE PATIENT OR OPERATING AREA, AND A NEW BLADE WAS OPENED TO CONTINUE THE SURGERY WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613359 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC PUERTO RICO OPERATIONS CO. 1884002 HG1YM5X 20681490047443

    Patients

    Seq Age Sex Outcome Treatment
    1