STLESS STEEL SIL 4X18IN 1 S/A V-37

Additional Manufacturer Narrative

PRODUCT COMPLAINT#: (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHEN WAS THE SUTURE BROKE (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY. WHEN WAS THE NEEDLE BROKE (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY. DID THE NEEDLE FALL INTO THE PATIENT? IF YES, WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? WHAT MEASURES WERE IMPLEMENTED TO RETRIEVE THE BROKEN PIECE? WAS THERE ANY ADDITIONAL TISSUE DAMAGE RESULTING FROM THE SEARCH FOR THE NEEDLE PIECE? DOES A FRAGMENT OF THE NEEDLE REMAIN IN THE PATIENT¿S TISSUE? IF YES, WAS MORE THAN HALF THE NEEDLE RETAINED IN THE PATIENT? IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE? IF YES, COULD YOU PLEASE PROVIDE THE SCHEDULED DATE FOR THE REMOVAL? IN WHICH TISSUE STRUCTURE WAS THE BROKEN NEEDLE LOCATED? WHAT IS THE SURGEON'S OPINION OF THE POTENTIAL CONSEQUENCES FOR THE PATIENT? PLEASE PROVIDE THE SOURCE OR TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP: PLEASE CLARIFY HOW THE PROCEDURE WAS COMPLETED: WAS THE DAMAGED PRODUCT USED ON THE PATIENT? PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. ADDITIONAL H11: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, IP-02633817. DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE AND WIRE ARE BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H 6. TYPE OF INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO 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.