BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11G BONE BIOPSY KIT

    MDR report key: 3180304 · Received June 20, 2013

    Report

    Report Number
    0001811755-2013-01433
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 30, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE NOT BEING RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DOCTOR WENT TO PULL-OUT THE NEEDLE DURING A BONE BIOPSY OF THE HUMERAL HEAD, THE NEEDLE GOT STUCK. THE DOCTOR THEN WIGGLED IT AND 1.5 CM BROKE OFF. THERE WAS NO MEDICAL INTERVENTION PERFORMED TO REMOVED THE NEEDLE. THE PATIENT WAS SENT HOME AND WAS NOT EXPERIENCING ANY ISSUES. THERE ARE NO PLANS TO REMOVE THE NEEDLE, HOWEVER IF IT BECOMES DISLODGED FROM ITS CURRENT LOCATION A SURGICAL PROCEDURE WOULD NEED TO BE PERFORMED TO REMOVE IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DOCTOR WENT TO PULL-OUT THE NEEDLE DURING A BONE BIOPSY OF THE HUMERAL HEAD, THE NEEDLE GOT STUCK. THE DOCTOR THEN WIGGLED IT AND 1.5 CM BROKE OFF. THERE WAS NO MEDICAL INTERVENTION PERFORMED TO REMOVED THE NEEDLE. THE PATIENT WAS SENT HOME AND WAS NOT EXPERIENCING ANY ISSUES. THERE ARE NO PLANS TO REMOVE THE NEEDLE, HOWEVER, IF IT BECOMES DISLODGED FROM ITS CURRENT LOCATION A SURGICAL PROCEDURE WOULD NEED TO BE PERFORMED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281511 11G BONE BIOPSY KIT INSTRUMENT, BIOPSY KNW STRYKER INSTRUMENTS-KALAMAZOO 12191012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other