BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE

    MDR report key: 1547588 · Received November 23, 2009

    Report

    Report Number
    9681442-2009-00131
    Event Type
    Malfunction
    Date Received
    November 23, 2009
    Date of Event
    October 21, 2009
    Report Date
    October 28, 2009
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    DWO
    PMA / PMN Number
    CLASS1 EXEMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE MFG AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO RELEASE. THE REVIEW SHOWED THAT NO REMARKABLE INCIDENTS OCCURRED DURING THE MFG PROCESS. AS PART OF ALL COMPLAINT INVESTIGATIONS, AN ATTEMPT TO EVALUATE THE SUBJECT DEVICE AS WELL AS HOW THE DEVICE WAS USED IS CONSIDERED. IN THIS PARTICULAR CASE, NO SAMPLE WAS RECEIVED FOR INVESTIGATION. BASED ON INFO AVAILABLE AND THE FACT THAT NO SAMPLE WAS RETURNED, THE REPORTED PROBLEM COULD NOT BE CONFIRMED. THE RESULT OF THE INVESTIGATION WAS INCONCLUSIVE AND THE ROOT CAUSE UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A 16G BONE BIOPSY NEEDLE BROKE WHILE IN THE PT'S TIBIA. THE BREAKAGE TOOK PLACE AS THE PHYSICIAN WAS TURNING THE NEEDLE INTO THE BONE. APPROXIMATELY 4MM OF THE TIP REMAINS IN THE BONE CORTEX. THERE IS NO PLAN FOR INTERVENTION TO REMOVE THE TIP FRAGMENT. THE PHYSICIAN COMPLETED THE BIOPSY USING ANOTHER BONE BIOPSY NEEDLE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE DWO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANRJ2199

    Patients

    Seq Age Sex Outcome Treatment
    1