BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE

    MDR report key: 1061567 · Received June 17, 2008

    Report

    Report Number
    9681442-2008-00080
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    KNW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNK. FOR THE SAMPLE EVAL, ONLY THE CANNULA WAS RECEIVED. ALL OTHER COMPONENTS OF THE SET WERE MISSING. THE CANNULA WAS BENT AT THE 5 CM MARKER AND 5 MM OF THE TIP WAS MISSING. THE COMPLAINT IS CONFIRMED. BASED ON THE INFO RECEIVED AND THE EVAL OF THE SAMPLE, THE ROOT CAUSE FOR THE DAMAGE TO THE PRODUCT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS USED IN PEDICLE BIOPSY. ROTATED THE HANDGRIP, BUT THE NEEDLE DID NOT ADVANCE. REMOVED THE STYLET AND USED A HAMMER TO MADE THE NEEDLE ADVANCE. OBSERVED THE NEEDLE BENT UNDER X-RAY. REMOVED THE NEEDLE AND FOUND THE TIP WAS FRACTURED. UNABLE TO REMOVE THE FRACTURED TIP WHICH STILL REMAINS IN VERTEBRAL BODY. IT WAS REPORTED THERE WAS NO HARM TO THE PT DUE TO THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE KNW ANGIOMED GMBH & CO. MEDIZINTE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other