ETHICON

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE TIP OF THE SUTURE BREAKS OFF WHEN SUTURING. RECURRING; HAPPENS EVERY SINGLE USE (CLINIC USES ABOUT 30 PER WEEK). PRODUCT IS NOT MODIFIED AND IS USED CORRECTLY ACCORDING TO VENDOR INSTRUCTIONS. THE CLINIC HAS NEVER HAD THIS PROBLEM BEFORE WITH THIS PRODUCT ("SOMETHING HAS CHANGED"). CLINIC IS ACCOUNTING FOR THE BROKEN TIPS, USING ADDITIONAL SUTURES TO COMPLETE PROCEDURES, AND IS ACTIVELY SOURCING NEW SUTURES. DOCTOR WOULD ALSO LIKE TO ADD HE HAS BEEN PRACTICING SURGERY FOR MORE THAN 25 YEARS, BOTH IN HIS PRIVATE SEDATION CLINIC AND AT THE (B)(6) HOSPITAL, AND HAS NEVER ENCOUNTERED THIS TYPE OF PROBLEM WITH ANY SUTURES DURING HIS CAREER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/30/2026 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. 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: *HOW MANY PROCEDURES/PATIENTS WERE AFFECTED BY THIS ISSUE? *HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY IN EACH PATIENT EVENT? IF POSSIBLE, PLEASE SPECIFY HOW MANY DEVICES WERE ASSOCIATED WITH LOT 10BE7Q, HOW MANY WITH LOT 10AEQD, AND HOW MANY WITH LOT 10BH9K. *LOT 109386 WAS ALSO PROVIDED; HOWEVER, THIS LOT NUMBER IS VALID FOR A SURGICEL/MESH PRODUCT. PLEASE CONFIRM WHETHER THIS IS THE CORRECT LOT NUMBER. *THE EVENT DESCRIPTION STATES THAT THE TIP OF THE NEEDLE BREAKS OFF DURING SUTURING; HOWEVER, THE PHOTOS PROVIDED SHOW BENT NEEDLES. COULD YOU PLEASE CLARIFY WHETHER THE NEEDLE TIP BROKE OFF AS A SEPARATE PIECE, OR WHETHER THE NEEDLE BENT WITHOUT BREAKING? *WERE THERE ANY PATIENT CONSEQUENCES ASSOCIATED WITH ANY OF THESE EVENTS? * PLEASE PROVIDE THE TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (E.G. NURSE, SURGEON, RISK MANAGER) * PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: A REQUEST FOR A RETURN KIT WAS REQUESTED JUST A COUPLE DAYS AGO, AS WE WERE NOT TOLD OF THE SPECIFICS IN REGARD TO SENDING THEM BACK. THE PRODUCT IS AVAILABLE AND ON ITS WAY BACK FROM THE CUSTOMER, BUT THEN WE WILL REQUIRE A PREPAID SHIPPING LABEL BE ISSUED TO SEND THE BOXES BACK. 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. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.