ETHICON

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. ADDITIONAL INFORMATION: D4, H4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: BATCH: 10BH9K, BATCH: 10AEQD, BATCH: 10BE7Q. THE FOLLOWING INFORMATION WAS RECEIVED: A REQUEST FOR A RETURN KIT WAS REQUESTED JUST A COUPLE DAYS AGO, AS WE WERE NOT TOLD OF THE SPECIFICS IN REGARDS 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. ADDITIONAL INFORMATION WAS REQUESTED; THE FOLLOWING WAS OBTAINED: HOW MANY PROCEDURES/PATIENTS WERE AFFECTED BY THIS ISSUE? WE DO 28 SURGERIES A WEEK I WOULD SAY AT LEAST 1/3 OF THOSE. 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. I DON¿T HAVE AN ANSWER FOR THIS THE BEST I CAN SAY IS EACH SURGERY WE USE 1 SUTURE AND DON¿T TRACK THE LOT NUMBERS OF WHAT WE USE ON EACH PT LOT 109386 THIS SHOULD BE 1093B6 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? WE TOOK THE PHOTOS BEFORE THEY BROKE OFF. WE HAVE HAD THE TIP BREAK OFF AND BE IN THE PT¿S MOUTH I WILL TAKE MORE PHOTOS. WERE THERE ANY PATIENT CONSEQUENCES ASSOCIATED WITH ANY OF THESE EVENTS? NON-THAT WE ARE AWARE OF AT THIS TIME PLEASE PROVIDE THE TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (E.G. NURSE, SURGEON, RISK MANAGER (B)(6) LICENSED SURGICAL DENTAL ASSISTANT ON BEHALF OF DR. (B)(6) - ORAL AND MAXILLOFACIAL SURGEON 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 I HAVE THEM ALL PACKAGED AND READY TO GO. IF THERE ARE FURTHER DETAILS REQUESTED, PLEASE LET US KNOW. AS WELL, KINDLY CONFIRM WHETHER A SHIPPING LABEL WILL BE PROVIDED FOR THE RETURN OF THE ITEMS FOR INVESTIGATION. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE 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 (B)(6) 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.