MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 36IN 0 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J358H
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Impaired Healing (2378); Fluid Discharge (2686)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent left knee arthroplasty in hospital on (b)(6) 2023 and suture was used for muscle and joint capsule sewing in a continuous suturing manner.The intraoperative sewing operation was smooth.About 28 days after the surgery, the doctor found that the patient had wound exudation and local fluctuation of wound, and the incision dehisced.The doctor performed the second surgery, and only a few knots remained in previous sewing site of the joint capsule and fascia.The doctor then removed the residual suture and performed debridement and replaced it with a new different type of absorbable suture.After symptomatic treatment, the patient's incision healing was improved, and no subsequent adverse event report was received.Additional information was requested.
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.H6 component code: g07002 device not returned.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.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 meant by ¿only a few knots remained¿? did the knots untie post operatively? was there a problem with suture absorption or breakage? please explain.Please provide the patient's weight, bmi at the time of index procedure.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture tied (square knot or multiple knots one end)? what tissue dehisced? please describe the appearance of the suture during the second procedure.Were there any patient stress factors that led to the suture untying, breaking or pulling out of the tissue? please describe any surgical intervention required for the wound dehiscence including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name?.
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 h6 codes.H6 component code: g07002 device not returned.Additional information was requested, and the following was obtained: what is meant by ¿only a few knots remained¿? did the knots untie post operatively? was there a problem with suture absorption or breakage? please explain.The surgeon believes the suture strength is too weak and result in only a few knots remained in sewing site.The following information was requested, but unavailable: please provide the patient's weight, bmi at the time of index procedure.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture tied (square knot or multiple knots one end)? what tissue dehisced? please describe the appearance of the suture during the second procedure.Were there any patient stress factors that led to the suture untying, breaking or pulling out of the tissue? please describe any surgical intervention required for the wound dehiscence including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? other information requested is unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.

• Brand Name: VCL CT BRD VIO 36IN 0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19818094
• Report Number: 2210968-2024-07585
• Device Sequence Number: 8891202
• Product Code: GAM
• UDI-Device Identifier: 10705031039254
• UDI-Public: (01)10705031039254(11)220912(17)270831(10)SK2AKB
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: J358H
• Device Lot Number: SK2AKB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female