BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTYCUT BONE BIOPSY NEEDLE

    MDR report key: 5059755 · Received September 7, 2015

    Report

    Report Number
    9681442-2015-00148
    Event Type
    Injury
    Date Received
    September 7, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 11, 2015
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    DWO
    PMA / PMN Number
    K874585
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUBJECT DEVICE HAS NOT BEEN PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE EVALUATION OF THE RETURNED DEVICE CONFIRMED THE BREAKAGE OF THE DISTAL END OF THE CANNULA. THE FRACTURE SITE WAS FOUND TO BE LOCATED AT THE THREAD. ON THE BASIS OF THE CONDITION OF THE SAMPLE, THERE IS NO INDICATION THAT A MATERIAL OR MANUFACTURING RELATED FAILURE MIGHT HAVE CAUSED THE DEFECT. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. THIS TYPE OF EVENT MAY BE ASSOCIATED WITH IMPROPER HANDLING OF THE DEVICE EITHER DURING ADVANCEMENT INTO THE BONE OR DURING REMOVAL FROM THE BONE. OSCILLATING MOVEMENTS OF THE CANNULA MAY LEAD TO THE REPORTED EVENT. ON THE BASIS OF THE INFORMATION AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE IFU SUPPLIED WITH THIS PRODUCT SUFFICIENTLY DESCRIBES THE CORRECT APPLICATION OF THE DEVICE. THE IFU STATES: "ADVANCE THE OSTYCUT BIOPSY CANNULA (...) TO THE PERIOSTEUM AND SCREW THE CANNULA INTO THE BONE WALL. FOR REASONS OF SAFETY, THE STYLET REMAINS WITHIN THE CANNULA DURING THIS PROCEDURE. IN CASE THE OSTYCUT BIOPSY CANNULA CANNOT BE REMOVED SMOOTHLY FROM THE PUNCTURED BONE AREA, DO NOT ATTEMPT TO LOOSEN THE OSTYCUT BIOPSY CANNULA BY OSCILLATING MOVEMENTS OF THE CANNULA. INSTEAD, IT IS ADVISED TO LOOSEN AND REMOVE THE OSTYCUT BIOPSY CANNULA FROM THE PUNCTURED BONE AREA BY SIMULTANEOUSLY APPLYING COUNTERCLOCKWISE ROTATION AND TRACTION."

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY UNDERWAY. ALTHOUGH THIS PRODUCT WAS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21 CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A DEVICE MARKET IN THE U.S. UNDER #K874585. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE BONE BIOPSY NEEDLE BROKE OFF INSIDE THE PATIENT'S BONE. THEREFORE, THE DOCTOR HAD TO RETRIEVE THE BROKEN TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591001 OSTYCUT BONE BIOPSY NEEDLE BONE BIOPSY NEEDLE DWO ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention