SUTURE UNKNOWN

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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE PROCEDURE ON (B)(6) 2025 SHOULD BE LIGAMENT RECONSTRUCTION SURGERY. THE PROCEDURE ON (B)(6) 2026 SHOULD BE DEBRIDEMENT SURGERY. 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: WHAT IS THE SURGEON¿S EXPERIENCE WITH THIS STRATAFIX SUTURE? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WHAT LIGAMENT WAS THE STRATAFIX SUTURE USED ON? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? FOR THE ORIGINAL INTENDED CLOSURE, HOW WERE ALL LAYERS CLOSED? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WHEN BEGINNING THE RUNNING SUTURE, DID THE SURGEON TAKE THE FIRST PASS ABOVE OR ADJACENT TO THE INCISION IN A DIRECTION AWAY FROM THE INCISION? AFTER TAKING THE FIRST PASS AWAY FROM THE INCISION, DID THE SURGEON THEN TAKE A PASS OF TISSUE PERPENDICULAR TO THE INITIAL PASS? IF SO, HOW MANY PERPENDICULAR PASSES? DID THE SURGEON THEN PROCEED WITH WOUND CLOSURE IN THE OPPOSITE DIRECTION OF THE FIRST PASS? WAS THE FIXATION TAB SEATED AGAINST THE TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE? WERE TWO REVERSE STITCHES PERFORMED ACROSS THE INCISION PRIOR TO CLOSURE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? CAN YOU DESCRIBE THE APPEARANCE OF THE STRATAFIX SUTURE DURING SECOND PROCEDURE? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? PRODUCT CODE AND LOT NUMBER FOR THE UNKNOWN SUTURE?

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE POSTOPERATIVE EFFECT WAS GOOD. AFTER DISCHARGE, THE PATIENT CHANGED DRESSINGS AT HOME BY HIMSELF. AT 102 DAYS AFTER SURGERY, THE PATIENT FOUND POOR WOUND HEALING. THE PATIENT WAS READMITTED FOR SURGERY ON (B)(6) 2026, 122 DAYS AFTER THE OPERATION AND IS CURRENTLY RECEIVING TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.