ETHICON

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. SITE CONFIRMED THAT THE SAMPLE WILL GET SENT OUT BY TOMORROW AT THE LATEST. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

THE NEEDLE WAS BREAKING OFF THE STERNAL WIRE. ERROR OCCURRED BUT DID NOT REACH THE INDIVIDUAL. NO INJURY WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: H 3. DEVICE EVALUATED BY MANUFACTURER? ADDITIONAL INFORMATION: H 6. COMPONENT CODE, H 6. TYPE OF INVESTIGATION, H 6. TYPE OF INVESTIGATION, H 6. INVESTIGATION CONCLUSIONS. H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE OPEN BOX WITH FIVE REPRESENTATIVE UNOPENED SAMPLES WAS RECEIVED FOR ANALYSIS. PRODUCT CODE M651G. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. UPON INITIAL INSPECTION OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE EXTERNAL PACKETS. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED, AND NO DEFECTS WERE DETECTED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT, AND THE PULL FORCE RESULTS WERE ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH BATCH IS RANDOMLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.