TEMNO NEEDLE BIOPSY 18GX20CM ADJ COAXIAL

Description of Event or Problem

THE PATIENT CAME IN FOR A DISC ASPIRATION WITH CT GUIDANCE. THE NEEDLE BROKE IN HALF DURING THE PROCEDURE AND WAS IMBEDDED BETWEEN THE L3 AND L4. THEY TRANSFERRED THE PATIENT TO FLUORO FOR FOREIGN BODY RETRIEVAL WITH ANESTHESIA. A SPINE SURGEON WAS CONSULTED AND PRESENT DURING RETRIEVAL PROCESS. THE OBJECT WAS RETRIEVED SUCCESSFULLY AND PATIENT WAS DISCHARGED. THE SALES REPRESENTATIVE INDICATED THERE WAS NO INJURY TO THE PATIENT. ON (B)(6) 2013, THE CUSTOMER (B)(6) PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE INTERVENTIONAL RADIOLOGIST (IR) DID NOT EXPERIENCE ANY DIFFICULTY INSERTING THE NEEDLE INTO THE PATIENT. THE IR NOTED THAT THE NEEDLE STARTED TO BEND WHEN THEY ADVANCED IT TO THE AREA. IT WAS AT THIS POINT, WHEN HE TRIED TO REMOVE THE NEEDLE, THAT IT BROKE IN HALF. THERE WAS NOTHING NOTED OF THE NEEDLE THAT WOULD INDICATE A DEFECT PRIOR TO USE. THE CUSTOMER ALSO INDICATED THAT THE SAMPLE PROVIDED INCLUDES THE PACKING, STYLET, INNER CANNULA AND THE BROKEN NEEDLE. ON (B)(6), THE CUSTOMER INDICATED THAT IT WAS THE COAXIAL NEEDLE THAT BROKE.

Additional Manufacturer Narrative

(B)(4) UPON COMPLETION OF THE SAMPLE EVALUATION/INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

(B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE INVOLVED IN THE EVENT WAS RECEIVED FOR EVALUATION. DURING THE APPLICABLE VISUAL INSPECTION, IT WAS NOTED THAT THE OUTER CANNULA OF THE UNIT'S COAXIAL COMPONENT WAS BROKEN. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE OTHER COMPONENTS OF THE DEVICE (COAXIAL'S STYLET AND TEMNO BIOPSY NEEDLE) WERE FOUND TO BE WITHOUT MALFUNCTION OR MANUFACTURING DEFECT. A REVIEW OF APPLICABLE MANUFACTURING, INSPECTION, AND PACKAGING PROCEDURES DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE APPLICABLE PROCEDURES REQUIRE MANUFACTURING PERSONNEL TO PERFORM VARIOUS VISUAL INSPECTIONS AND FUNCTIONAL TESTS PRIOR TO RELEASING THE PRODUCT. ADDITIONALLY, PACKAGING PERSONNEL ARE REQUIRED TO VERIFY EACH UNIT PRIOR TO INITIATING PACKAGING OPERATIONS. NO ISSUES WERE FOUND DURING REVIEW OF THE INTERNAL PRODUCTION RECORDS FOR THE LOT INDICATED THAT COULD RESULT IN THE REPORTED CONDITION. THIS INCLUDES REVIEW OF ALL RAW MATERIAL AND COMPONENTS USED DURING THE MANUFACTURE OF THE LOT INVOLVED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED CONDITION COULD NOT BE DETERMINED AS THE PRODUCT WAS USED OFF LABEL. WHILE REVIEWING THE INCIDENT DESCRIPTION, IT WAS DETERMINED THAT THE PRODUCT WAS BEING USED AROUND THE L3 AND L4 VERTEBRAL BODIES, WHICH IS NOT PART OF THE INDICATIONS FOR USE OF THIS PRODUCT. INSTRUCTIONS FOR USE FOR THIS DEVICE AND THE COAXIAL INTRODUCER SPECIFY THAT THE PRODUCT IS INTENDED TO BE USED IN SOFT TISSUE SUCH AS KIDNEY, LIVER, LUNG AND VARIOUS SOFT TISSUE MASSES; NOT INTENDED FOR USE IN BONE. IT IS CONSIDERED THE USE IN THE SPINE IS A CONTRAINDICATION, OFF LABEL USE. BASED ON THE ABOVE STATED, IT HAS BEEN DETERMINED THAT THE BIOPSY PROCEDURE PERFORMED WITH THIS DEVICE MAY BE THE ROOT CAUSE FOR THE REPORTED INCIDENT. NO ACTION PLAN IS REQUIRED AT THIS TIME AS IT WAS DETERMINED THAT THE ROOT CAUSE IS NOT RELATED TO ANY MANUFACTURING PROCESSES. FEEDBACK REGARDING THE INSTRUCTIONS FOR USE AND INTENDED USE OF THE PRODUCT WILL BE PROVIDED TO THE CUSTOMER.