STLESS STEEL SIL 4X18IN 5 S/A V-40

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. ADDITIONAL INFORMATION; H6. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: AFTER INVESTIGATION, THE SPECIFIC AGE AND GENDER OF THE PATIENT WERE UNKNOWN, AND THE PATIENT UNDERWENT MEDIAN THORACOTOMY CARDIAC SURGERY IN THE HOSPITAL ON (B)(6) 2025 (THE SPECIFIC DIAGNOSIS AND SURGICAL NAME OF THE PATIENT WERE UNKNOWN). THE SURGEON USED THE SUTURE (M650G) TO CLOSE THE STERNUM IN THE WAY OF INTERRUPTED SUTURING. DURING THE SURGERY, TWO PRODUCTS OCCURRED PULL OFF SUTURE NEEDLE, AND ONE OF THEM RESULTED IN NEEDLE STICK INJURY TO THE SURGEON. THE SURGEON REPLACED WITH A NEW SUTURE (THE SPECIFIC PRODUCT INFORMATION WAS UNKNOWN) TO CONTINUE THE SUTURING. THE SUBSEQUENT SURGERY WENT SMOOTHLY. BECAUSE THIS PATIENT WAS A SYPHILIS PATIENT, RESULTING IN THE OCCURRENCE OF OCCUPATIONAL EXPOSURE TO THE SURGEON, THE SURGEON PERFORMED ORAL ANTIBIOTIC TREATMENT AFTER THE OCCURRENCE OF OCCUPATIONAL EXPOSURE. THIS EVENT PROLONGED THE SURGICAL TIME BY APPROXIMATELY 10 MINUTES, RESULTING IN NEEDLE STICK INJURY TO THE SURGEON AND OCCUPATIONAL EXPOSURE. NO SUBSEQUENT ADVERSE EVENTS WERE REPORTED. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: QUESTIONS FOR THE PATIENT WHO UNDERWENT OPEN HEART SURGERY: ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? DID THE NEEDLE(S) FALL INTO THE PATIENT DURING THE OPEN HEART PROCEDURE? IF YES, WERE THE NEEDLE(S) EASILY REMOVED DURING THE PROCEDURE? IF NO, PLEASE EXPLAIN. WAS ADDITIONAL DISSECTION REQUIRED IN OTHER TISSUES OTHER THAN THE TARGET TISSUE? IF YES, PLEASE DESCRIBE. WERE THERE ANY ADVERSE PATIENT CONSEQUENCES FOR THE PATIENT WHO UNDERWENT THE OPEN HEART PROCEDURE DUE TO THE EVENT OF THE SUTURE PULLING OFF THE NEEDLE? WAS THE PATIENT TREATMENT OR POST-OPERATIVE CARE ALTERED IN ANY WAY DUE TO THE EVENT OF THE SUTURE PULLING OFF THE NEEDLE? IF YES, PLEASE EXPLAIN. WAS THERE ANY PATIENT IMPACT (IE. ADDITIONAL TREATMENT REQUIRED) AND/OR ADVERSE PATIENT OUTCOME DUE TO THE EVENT OF THE SUTURE PULLING OFF THE NEEDLE? WHAT IS THE PATIENT¿S CURRENT STATUS? QUESTIONS FOR THE SURGEON WHO WAS PRICKED BY A NEEDLE: DID 2 DEVICES HAVE THE ISSUE OF THE SUTURE PULLING OFF THE NEEDLE DURING THE PROCEDURE? WAS THE SURGEON PRICKED BY ONLY 1 OF THE NEEDLES? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? DID THE SURGEON REQUIRE ANY MEDICAL TREATMENT/INTERVENTION DUE TO THE NEEDLE PRICK? IF YES, PLEASE DESCRIBE. WHAT IS THE SURGEON¿S CURRENT STATUS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? SURGEON¿S NAME? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: QUESTIONS FOR THE PATIENT WHO UNDERWENT OPEN HEART SURGERY: WAS THE PATIENT TREATMENT OR POST-OPERATIVE CARE ALTERED IN ANYWAY DUE TO THE PROLONGED SURGERY TIME? IF YES, PLEASE EXPLAIN. WAS THERE ANY PATIENT IMPACT (IE. ADDITIONAL TREATMENT REQUIRED) AND/OR ADVERSE PATIENT OUTCOME DUE TO THE PROLONGED SURGERY? WHAT IS THE PATIENT¿S CURRENT STATUS?

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN-HEART SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. IT'S UNCERTAIN HOW LONG OPERATION TIME WAS PROLONGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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. QUESTIONS FOR THE PATIENT WHO UNDERWENT OPEN HEART SURGERY: ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? DID THE NEEDLE(S) FALL INTO THE PATIENT DURING THE OPEN-HEART PROCEDURE? IF YES, WERE THE NEEDLE(S) EASILY REMOVED DURING THE PROCEDURE? IF NO, PLEASE EXPLAIN. WAS ADDITIONAL DISSECTION REQUIRED IN OTHER TISSUES OTHER THAN THE TARGET TISSUE? IF YES, PLEASE DESCRIBE. WERE THERE ANY ADVERSE PATIENT CONSEQUENCES FOR THE PATIENT WHO UNDERWENT THE OPEN-HEART PROCEDURE DUE TO THE EVENT OF THE SUTURE PULLING OFF THE NEEDLE? WAS THE PATIENT TREATMENT OR POST-OPERATIVE CARE ALTERED IN ANY WAY DUE TO THE EVENT OF THE SUTURE PULLING OFF THE NEEDLE? IF YES, PLEASE EXPLAIN. WAS THERE ANY PATIENT IMPACT (IE. ADDITIONAL TREATMENT REQUIRED) AND/OR ADVERSE PATIENT OUTCOME DUE TO THE EVENT OF THE SUTURE PULLING OFF THE NEEDLE? WHAT IS THE PATIENT¿S CURRENT STATUS? QUESTIONS FOR THE SURGEON WHO WAS PRICKED BY A NEEDLE: DID 2 DEVICES HAVE THE ISSUE OF THE SUTURE PULLING OFF THE NEEDLE DURING THE PROCEDURE? WAS THE SURGEON PRICKED BY ONLY 1 OF THE NEEDLES? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? DID THE SURGEON REQUIRE ANY MEDICAL TREATMENT/INTERVENTION DUE TO THE NEEDLE PRICK? IF YES, PLEASE DESCRIBE. WHAT IS THE SURGEON¿S CURRENT STATUS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? SURGEON¿S NAME? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION.

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. ADDITIONAL H6 TYPE OF INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.