SURGICEL FIBRILLAR

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT HUMERAL LESION RESECTION, BIOPSY, BONE GRAFTING, HUMERAL FRACTURE, OPEN REDUCTION, STEEL PLATE INTERNAL FIXATION SURGERY ON (B)(6) 2026 AND ABSORBABLE HEMOSTAT WAS USED. AFTER THE PATIENT WAS ADMITTED, ROUTINE EXAMINATIONS WERE COMPLETED, PREOPERATIVE PREPARATIONS WERE MADE, AND SURGERY WAS PERFORMED. SUTURE WAS USED DURING THE SURGERY, AND THE SURGERY WENT SMOOTHLY. AFTER THE SURGERY, INFECTION PREVENTION AND SYMPTOMATIC SUPPORTIVE TREATMENT WERE GIVEN, AND THE WOUND DRESSING WAS CHANGED REGULARLY. POSTOPERATIVE PATHOLOGICAL EXAMINATION SUGGESTS OSTEOCHONDROMA IN THE RIGHT HUMERUS. POST-OP, THE PATIENT EXPERIENCED WOUND SECRETION. SIX DAYS AFTER THE PROCEDURE, WHEN CHANGING THE DRESSING, IT WAS FOUND THAT THERE WAS WOUND EXUDATE AND BACTERIA CULTURE SHOWED (SECRETION): STAPHYLOCOCCUS LUDDEN. AFTER THE DRESSING WAS CHANGED REPEATEDLY, EXUDATE BACTERIA CULTURE ALL SUGGESTED STAPHYLOCOCCUS LUDDEN. THE PATIENT UNDERWENT RE-OPERATION 23 DAYS AFTER THE FIRST SURGERY. THE PROCEDURE ON (B)(6) 2026 WAS AN EXCISION DEBRIDEMENT SURGERY FOR SKIN AND SOFT TISSUE WOUNDS, INFECTIONS, OR BURNS IN THE RIGHT UPPER ARM, VANCOMYCIN LOADING AND BONE CEMENT FILLING SURGERY, VSD SURGERY. DURING THE PROCEDURE, THE SUTURE WAS FOUND TO BE UNABSORBED, WITH TIGHT SUTURE TISSUE. AFTER REMOVING THE SUTURE, NO OBVIOUS OSTEOGENIC REACTION WAS OBSERVED IN THE BONE DEFECT AREA. VANCOMYCIN ANTI INFECTION TREATMENT WAS GIVEN AFTER SURGERY, AND THE WOUND WAS REPEATEDLY CHANGED. THE PATIENT'S WOUND HEALING IS NOW GOOD, AND INFLAMMATORY INDICATORS HAVE RETURNED TO NORMAL. THE PATIENT'S VITAL SIGNS ARE STABLE AND THEIR BODY TEMPERATURE IS NORMAL. TWENTY-ONE DAYS AFTER THE SECOND SURGERY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). 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: ACCORDING TO FEEDBACK OF THE SALES REP ON 7-JULY-2026 VIA PHONE, CODE: VCP345H LOT:10A12H) AND CODE: 1963, LOT: 10A5AZ OCCURRED IN ONE OPERATION. UPDATED EVENT DESCRIPTION: THE PATIENT UNDERWENT ROUTINE EXAMINATIONS AND PREOPERATIVE PREPARATIONS UPON ADMISSION, AND UNDERWENT SURGERY. THE DOCTOR USED THE PRODUCT DURING THE SURGERY, AND THE SURGERY WENT SMOOTHLY. AFTER THE SURGERY, INFECTION PREVENTION AND SYMPTOMATIC SUPPORTIVE TREATMENT WERE GIVEN, AND THE WOUND DRESSING WAS CHANGED REGULARLY. POSTOPERATIVE PATHOLOGICAL EXAMINATION SUGGESTS OSTEOCHONDROMA IN THE RIGHT HUMERUS. ON THE 6TH DAY AFTER SURGERY, WHEN THE PATIENT CHANGED DRESSING, THERE WAS EXUDATE FROM THE WOUND AND BACTERIAL CULTURE SHOWED (SECRETION) OF STAPHYLOCOCCUS AUREUS. AFTER REPEATED WOUND DRESSING CHANGES, BACTERIAL CULTURE SHOWED STAPHYLOCOCCUS AUREUS, AND CONSERVATIVE TREATMENT DID NOT RELIEVE THE SYMPTOMS. ON THE 23RD DAY AFTER SURGERY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE UNDER GENERAL ANESTHESIA CALLED "EXCISION DEBRIDEMENT OF SKIN AND SOFT TISSUE WOUNDS, INFECTIONS, OR BURNS IN THE RIGHT UPPER ARM WITH VANCOMYCIN LOADING AND BONE CEMENT FILLING IN THE BONE GAP VSD SURGERY". THE DOCTOR REMOVED THE IMPLANT DURING THE SURGERY, AND NO OBVIOUS OSTEOGENIC REACTION WAS OBSERVED IN THE BONE DEFECT AREA. AFTER SURGERY, VANCOMYCIN ANTI INFECTION TREATMENT WAS GIVEN, AND THE WOUND DRESSING WAS REPEATEDLY CHANGED. THE PATIENT'S WOUND HEALING WAS GOOD AND INFLAMMATORY INDICATORS RETURNED TO NORMAL. THE PATIENT'S VITAL SIGNS ARE STABLE AND THEIR BODY TEMPERATURE IS NORMAL. THE PATIENT WAS DISCHARGED ON THE 44TH DAY AFTER SURGERY. ¿ THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: --RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. PLEASE REFER TO THE EVENT DESCRIPTION, OTHER INFORMATION REQUESTED IS UNKNOWN. 1. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? 2. WERE ANY CONCOMITANT PROCEDURES PERFORMED? 3. WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? 4. ON WHAT TISSUE WAS THE SUTURE USED? 5. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? 6. FOR THE ORIGINAL INTENDED CLOSURE, HOW WERE ALL LAYERS CLOSED? 7. HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? 8. PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE). PLEASE PROVIDE THE ONSET DATE/TIME OF INFECTION FROM THE INITIAL SURGICAL PROCEDURE. 9. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? 10. DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? 11. DOES THE SURGEON BELIEVE THE OSTEOCHONDROMA IN THE RIGHT HUMERUS WAS BECAUSE OF THE SUTURE? 12. WAS THE SUTURE EXPECTED TO BE ABSORBED AT 23 DAYS? 13. ABSORPTION FOR VICRYL PLUS SUTURE IS ESSENTIALLY COMPLETE BY 56-70 DAYS. 14. WERE CULTURES AND SENSITIVITIES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. 15. WHAT WERE THE RESULTS OF THE BIOPSY? 16. HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? 17. WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE 18. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? 19. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? 20. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? 21. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? 22. WHAT IS THE PATIENT'S CURRENT STATUS? DEVICE HISTORY REVIEW ==> "A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH 10A5AZ, 1963-12 AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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.