BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BLADE

    MDR report key: 7500276 · Received May 9, 2018

    Report

    Report Number
    3004209178-2018-10494
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    March 26, 2018
    Report Date
    May 9, 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

    THE PRODUCT ANALYSIS CONFIRMED THAT ONE DEVICE, PART NUMBER 1884002 FROM LOT HG1WYGP, WAS RECEIVED WITH THE INNER CUTTER TIP BROKEN OFF. A MICROSCOPE AND CALIPERS WERE USED TO FURTHER ASSESS THE RETURNED SAMPLE. THE FRAGMENTED PORTION WAS APPROXIMATELY 0.24" IN LENGTH WITH THE DETACHMENT SITE OCCURRING AT THE FIRST PROXIMAL TOOTH VALLEY. THE INNER ASSEMBLY WAS DEFORMED IN SUCH A WAY THAT INDICATES THE INNER BLADE TEETH IMPACTED THE OUTER CUTTING SURFACE WHILE MOVING BOTH THE CLOCKWISE AND COUNTERCLOCKWISE DIRECTIONS WHICH RESULTED IN THE OBSERVED BREAK. THE IMPACTS MARKINGS WERE AT THE SECOND AND THIRD PROXIMAL VALLEYS, 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 OFF. THE TIP WAS RETRIEVED. THERE WAS A DELAY OF LESS THAN 10 MINUTES AND NO PATIENT INJURY OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343319 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC PUERTO RICO OPERATIONS CO. 1884002 HG1WYGP 20681490047443

    Patients

    Seq Age Sex Outcome Treatment
    1