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

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/14/2024. H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. 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. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: PLEASE CONFIRM THAT THE NEEDLE DETACHED FROM THE SUTURE? OR DID THE SUTURE BREAK? THE SUTURE BROKE AFTER THE FIRST STERNAL PASSAGE. IS IT KNOWN HOW MANY OF EACH LOT (TBMKPT & TCMBEJ) WAS USED DURING EACH PROCEDURE? PLEASE SPECIFY. UNFORTUNATELY, THIS INFORMATION IS UNKNOWN. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WE DON'T HAVE THIS INFORMATION. DATE AND NAME OF INDEX SURGICAL PROCEDURE? PEDIATRIC CARDIAC SURGERY (CONGENITAL). THE DATES ARE NOT AVAILABLE. THE PROBLEM IS RECURRENT SINCE THE LAST FEW MONTHS. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? CONGENITAL CARDIAC PEDIATRIC SURGERY. WE DON'T HAVE MORE DETAILS. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? TISSUE CONDITION IS UNKNOW FOR ALL THE PATIENTS. THE SURGERIES WERE ON BABIES, SO THE TISSUES WERE NOT CALCIFIED, FRAGILE OR DISEASED. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? UNKNONWN. WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? NEEDLE HOLDER (STERNAL). WHERE WAS THE NEEDLE GRASPED DURING USE? 2/3 OF THE DISTANCE FROM THE POINT OF THE NEEDLE. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? HERE¿S A REVISED VERSION OF YOUR TEXT WITH CORRECTIONS AND MODIFICATIONS: BOTH PHYSICIANS HAVE BEEN USING THE SAME STEEL WIRE (ETHICON WIRE 1) FOR THE PAST 20¿30 YEARS WITHOUT ENCOUNTERING ANY ISSUES WITH THE WIRE BREAKING AFTER THE FIRST PASS. HOWEVER, IN THE LAST FEW MONTHS, THEY¿VE STARTED TO EXPERIENCE THIS PROBLEM. THEY HAVE NOT CHANGED THEIR TECHNIQUE OR THE INSTRUMENTS THEY USE. THEY SUSPECT THE ISSUE MAY BE DUE TO A SLIGHT CHANGE IN THE MANUFACTURING PROCESS, WHICH IS CAUSING THE WIRE TO BREAK AFTER THE INITIAL PASS. THIS ISSUE ONLY AFFECTS THE STEEL WIRE OF CALIBER 1 USED FOR BABIES, AS THEY DO NOT ENCOUNTER THE SAME PROBLEM WITH OTHER WIRE CALIBERS. THIS IS WHY THEY BELIEVE IT MAY BE A MANUFACTURING DEFECT. WHAT IS THE PATIENT'S CURRENT STATUS? IN RECOVERY WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. THE PRODUCT HAVE BEEN RETURNED. TRACKING INFO : (B)(4). PLEASE DESCRIBE WHY AN ABSORBABLE SUTURE WAS USED WHEN THE STEEL WIRE WAS NOT ABLE TO BE USED? IN THE PEDIATRIC POPULATION, ABSORBABLE SUTURES MAY BE USED FOR SMALLER PATIENTS AS AN ALTERNATIVE TO STEEL WIRES. HOWEVER, THE PREFERRED METHOD REMAINS STEEL WIRES, AS I MENTIONED IN THE FORM, TO PROVIDE PROTECTION IN CASE ADDITIONAL SURGERIES ARE NEEDED. THE SURGEON EXPLAINED THAT BABIES' STERNUMS HEAL VERY QUICKLY, WHICH IS WHY ABSORBABLE SUTURES CAN BE AN OPTION. H3 INVESTIGATIONAL SUMMARY; THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. TWO UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. THE PRODUCT CODE M660G IS MULTI-STRAND AND CONTAINS FOUR STRANDS PER PACKET. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED. THE SWAGE AND ATTACHMENT AREA WERE NOTED AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND NO ANOMALIES WERE OBSERVED DURING THE EVALUATION. THE FUNCTIONAL TEST WAS IN TWO NEEDLE SUTURES PERFORMED USING INSTRON EQUIPMENT AND THE PULL FORCE RESULT WAS ABOVE THE MINIMUM REQUIREMENTS. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH 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. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. 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. PLEASE CONFIRM THAT THE NEEDLE DETACHED FROM THE SUTURE? OR DID THE SUTURE BREAK? IS IT KNOWN HOW MANY OF EACH LOT (TBMKPT & TCMBEJ) WAS USED DURING EACH PROCEDURE? PLEASE SPECIFY. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE AND NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT INSTRUMENTS WERE USED TO GRASP THE NEEDLE? WHERE WAS THE NEEDLE GRASPED DURING USE? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. PLEASE DESCRIBE WHY AN ABSORBABLE SUTURE WAS USED WHEN THE STEEL WIRE WAS NOT ABLE TO BE USED?

Description of Event or Problem

IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT A CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER THE FIRST PASS THROUGH THE BABY'S STERNUM, THE NEEDLE DETACHED FROM THE WIRE, PREVENTING THE SURGEON FROM MAKING THE SECOND PASS TO CLOSE THE THORAX. AS A RESULT OF THE STEEL WIRE BREAKING, THE SURGEON HAD TO CLOSE THE BABY'S STERNUM WITH AN ABSORBABLE SUTURE INSTEAD OF A PERMANENT STEEL WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. IT WAS OPINED BY THE SURGEON THAT IT IS PREFERABLE TO USE A STEEL WIRE FOR CLOSING A BABY¿S STERNUM, AS THE BABY WILL OFTEN NEED A SECOND SURGERY. THE STEEL WIRE PROVIDES PROTECTION WHEN REOPENING THE STERNUM FOR A SUBSEQUENT PROCEDURE. HOWEVER, WITH A STERNUM CLOSED WITH AN ABSORBABLE SUTURE, THE PATIENT DOES NOT BENEFIT FROM THIS PROTECTION, AND THERE IS A RISK THAT THE SAW COULD PENETRATE THE HEART DURING REOPERATION. ADDITIONAL INFORMATION WAS REQUESTED.