BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEO-SITE BONE BIOPSY NEEDLE

    MDR report key: 8271915 · Received January 23, 2019

    Report

    Report Number
    1820334-2019-00119
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    October 26, 2018
    Report Date
    January 23, 2019
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002123748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K170008. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), VISUAL INSPECTION, QUALITY CONTROL AND SPECIFICATIONS OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE CUSTOMER REPORTED THAT THE DEVICES, TWO OSTEO-SITE BONE BIOPSY NEEDLE, HAD THE NEEDLE CANNULAS SEPARATE FROM THE HANDLES DURING A SPINAL FUSION PROCEDURE. THE INVESTIGATION FOUND THAT THE AFFECTED COMPONENT IS SUPPLIED TO COOK FROM AN EXTERNAL SUPPLIER. COOK REQUESTED THAT THE SUPPLIER INVESTIGATE THIS OCCURRENCE AND SENT THE COMPLAINT DEVICE AND UNUSED DEVICES TO THE SUPPLIER FOR INVESTIGATION. THE SUPPLIER INSPECTED THE DEVICE AND CONCLUDED THAT THE TORQUE TANGS WERE MISSING FROM THE CANNULA WHICH CONTRIBUTED TO THE HANDLE DETACHMENT. THE UNUSED DEVICES WERE CONFORMING. BASED ON THE SUPPLIER INVESTIGATION AND CUSTOMER TESTIMONY, WE FOUND THE FAILURE MODE FOR THE DEVICE COMPLAINT TO BE TORQUE TANGS MISSING FROM CANNULA. THEREFORE, THE INVESTIGATION CONCLUSION FOR THE COMPLAINT IS ¿MANUFACTURING DEFICIENCY SUPPLIER.¿ THE DEVICE HISTORY RECORD FOR DEVICE LOT 8682919 WAS REVIEWED AND FOUND NO NON-CONFORMANCES. THERE IS NO EVIDENCE TO SUGGEST THERE ARE NON-CONFORMING DEVICES IN HOUSE OR IN FIELD. WE COMPLETED A RISK ANALYSIS AND DETERMINED THAT NO ADDITIONAL RISK REDUCTION ACTIVITIES ARE NEEDED AT THIS TIME. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE COMPLAINT HAS BEEN CONFIRMED DUE TO CUSTOMER TESTIMONY AND RETURNED DEVICE SUPPLIER INVESTIGATION. THE SUPPLIER IMPLEMENTED A CORRECTIVE ACTION AS A RESULT OF THIS COMPLAINT. THE SUPPLIER RETRAINED THE RELEVANT PERSONNEL REGARDING THIS EVENT. COOK INCORPORATED WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED A OSTEO-SITE BONE BIOPSY NEEDLE WAS USED DURING A SPINAL FUSION PROCEDURE. AS REPORTED DURING THE PROCEDURE A PART OF THE HANDLE SEPARATED FROM THE NEEDLE. A SECOND OSTEO-SITE BONE BIOPSY NEEDLE WAS USED AND ENCOUNTERED THE SAME ISSUE WITH SEPARATION FROM THE HANDLE. A THIRD OSTEO-SITE BONE BIOPSY NEEDLE WAS USED, AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE EFFECTS TO THE PATIENT. PHYSICIAN REPORTED RESISTANCE WAS ENCOUNTERED WHEN REMOVING ALL DEVICES. AS REPORTED, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64583 OSTEO-SITE BONE BIOPSY NEEDLE KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 8682919 00827002123748

    Patients

    Seq Age Sex Outcome Treatment
    1