BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6" 17G CURVED DEK KIT

    MDR report key: 4130653 · Received September 30, 2014

    Report

    Report Number
    0001811755-2014-03432
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 1, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K032473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAIMED BROKEN AUGER CONDITION WAS CONFIRMED. IN COLLABORATION WITH THE SUBJECT MATTER EXPERT AND BASED ON COMPLAINT INVESTIGATIONS PREVIOUSLY CONDUCTED, AND RETURNED COMPONENTS OBSERVATIONS; THE MOST PROBABLE CAUSE WAS IDENTIFIED AS A BENT / BROKEN CANNULA / AUGER INDUCED DURING THE PROCEDURE. IT CAUSES FRICTION AND VIBRATION BETWEEN THE CANNULA AND AUGER (PROBE), CONSEQUENTLY, THE AUGER COULD JAMMED INSIDE THE CANNULA OR THE FRICTION BETWEEN THE CANNULA AND AUGER HEATS UP THE PROBE MATERIAL AND EVENTUALLY IT COULD CAUSE THE AUGER (PROBE) AND /OR THE CANNULA BREAKAGE. THE DEVICE WAS SCRAPPED AT THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEKOMPRESSOR KIT WAS BEING USED IN A PROCEDURE WHEN THE PROBE BROKE DURING INSERTION REQUIRING IT TO BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESCHEDULED DUE TO THE EVENT WHICH REQUIRES MILD SEDATION. THERE WERE NO PATIENT OR USER INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608289 6" 17G CURVED DEK KIT ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other