BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEO-SITE BONE BIOPSY NEEDLE

    MDR report key: 8797563 · Received July 17, 2019

    Report

    Report Number
    1820334-2019-01714
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    July 11, 2019
    Report Date
    October 14, 2019
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002130180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED SO A PHYSICAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT LOT SHOWED NO RELATED NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS UNDER THIS LOT NUMBER AT THE TIME OF THIS INVESTIGATION. SINCE THERE ARE NO RELATED NONCONFORMANCES OR COMPLAINTS FOR THE SAME FAILURE MODE FROM THIS LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING CAUSES CONTRIBUTED TO THE DEVICE FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ALSO SENT REPORT TO FDA: UNKNOWN. PMA/510(K) #: K170008. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2019 AN OSTEO-SITE BONE BIOPSY NEEDLE WAS USED IN AN UNKNOWN MALE PATIENT DURING A BONE CEMENT INJECTION PROCEDURE. THE OPERATOR INTENDED TO PERCUTANEOUSLY INJECT THE BONE CEMENT TO THE LUMBAR SPINE. AS REPORTED, THE USER INSERTED THE COMPLAINT DEVICE BUT ¿FELT SOMETHING WRONG WITH THE NEEDLE DURING THE PUNCTURE.¿ UPON CHECKING THE NEEDLE, IT WAS OBSERVED THAT THE NEEDLE WAS BENT. THE USER ALSO COMMENTED THAT THE NEEDLE WAS ¿PROBABLY¿ BENT BEFORE USE. THE DEVICE WAS REPLACED WITH A NEW SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592529 OSTEO-SITE BONE BIOPSY NEEDLE KNW INSTRUMENT, BIOPSY KNW COOK INC N/A 7158903 00827002130180

    Patients

    Seq Age Sex Outcome Treatment
    1