BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTY-CUT BONE BIOPSY NEEDLE

    MDR report key: 1130460 · Received August 20, 2008

    Report

    Report Number
    9681442-2008-00128
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    KNW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED BECAUSE THE SAME OR SIMILAR DEVICE IS MARKETED IN THE UNITED STATES AS AN OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE. THE CANNULA WAS RETURNED WITH THE TIP BROKEN OFF AT THE FIRST THREAD. THE BROKEN OFF SEGMENT WAS MISSING. THE CANNULA WAS DETACHED FROM THE HUB. THE HUB WAS INCLUDED. THE STYLET AND OBTURATOR WERE ALSO INCLUDED. THE COMPLAINT IS CONFIRMED. BASED ON THE EVAL PERFORMED AND THE INFO AVAILABLE, THE ROOT CAUSE FOR THE CANNULA FRACTURE COULD NOT BE DETERMINED. AS NO SPECIFIC LOT NUMBER WAS AVAILABLE, NO DHR REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIP OF CANNULA WAS DAMAGED. BASE OF THE CANNULA WAS DAMAGED. BOTH ON THE USED SAMPLE. PROCEDURE WAS A BIOPSY ON RIGID TISSUE. A PATH WAS MADE WITH A COMPETITOR'S DRILL, OSTY CUT WAS INSERTED, REMOVED THE STYLET, ATTACHED THE HANDLE AND APPLIED TORQUE, THEN RESISTANCE WAS ENCOUNTERED. MORE TORQUE WAS APPLIED WHICH MADE THE CANNULA DETACH FROM THE BASE. REMOVED THE CANNULA AND THE TIP CANNULA WAS DAMAGED AND REMAINED IN BODY. FRACTURED CANNULA WAS REMOVED BY OPEN INCISION. NOTE: HAMMER WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTY-CUT BONE BIOPSY NEEDLE KNW ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention