STLESS STEEL SIL 4X18IN 7 S/A CPX

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WE HAVE HAD A PROBLEM WITH A BATCH OF WIRES, WHERE THE WIRE HAS COME AWAY FROM THE NEEDLE ON MULTIPLE OCCASIONS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETH FOR EVALUATION. VISUAL INSPECTION REVEALED THAT FORTY UNOPENED SAMPLES WERE RECEIVED FOR ANALYSIS. PRODUCT CODE M624G. AS PER THE SAMPLING PLAN, A VISUAL INSPECTION WAS PERFORMED ON THIRTEEN SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS WITH NO ANOMALIES OBSERVED ALONG THE STRAND DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT, AND THE PULL FORCE RESULTS WERE ABOVE THE MINIMUM REQUIREMENTS. AS PART OF ETH QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 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, AND NO NON-CONFORMANCES WERE IDENTIFIED. "D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN IS NOT AVAILABLE.

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. CORRECTED DATA: H11 - ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: DID THE EVENT OCCUR DURING ONE OR MULTIPLE PROCEDURES? ON MULTIPLE OCCASIONS. PLEASE CONFIRM THE NUMBER OF PATIENTS AFFECTED BY THE ALLEGED DEFICIENCY. AROUND 5. HOW MANY DEVICES DEMONSTRATED THE REPORTED ALLEGED DEFICIENCY ON EACH PROCEDURE? EACH PACK WE OPENED WAS A PROBLEM, AROUND 30 ITEMS. WHEN DID THE ALLEGED DEFICIENCY OCCUR (REMOVAL FROM PACKAGE / DURING HANDLING PRIOR TO USE ON PATIENT/ DURING PASSAGE THROUGH TISSUE / DURING TYING / POST-OP)? IF DIFFERENT, PLEASE EXPLAIN. PASSING THROUGH THE TISSUE. DID THIS EVENT CONTRIBUTE TO ANY PATIENT ADVERSE EVENT? IF YES, PLEASE EXPLAIN. NO, NOT AT PRESENT. WILL UPDATE YOU ACCORDINGLY IF, WE HAVE ANY ISSUES OF DEHISCENCE.