MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP316H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint#: (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformance's were identified.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 following information was requested, but unavailable: was\were the needle piece(s) retrieved during the same procedure? what measures were taken to retrieve the broken piece(s)? was there any additional tissue damage as a result of searching for the needle piece(s)? was there any medical or surgical intervention performed (product removed; re-operation; re-suturing; re-closure; drainage)? if so, please specify.Was a prescription for steroids or antibiotics issued for the patient's recovery? if so, please provide the medication name, route, and dosage.What is the current status of the patient? received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.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: were the needle piece(s) retrieved during the same procedure? what instruments were used to grasp the needle? where was the needle grasped during use? what was the size of the broken needle fragment? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? please describe any medical/surgical intervention required for this suture event including dates and results.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?.
Event or Problem Description
It was reported that a patient underwent an anal fistula surgery on (b)(6) 2025 and 5 days after surgery, the patient experienced sudden active bleeding.The patient was sutured in the ward on (b)(6) 2025 to stop the bleeding.During the suturing process, the needle broke in the patient's body.The emergency ct confirmed the location, and the broken needle was surgically taken out on the same day.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Additional information: h6.The following information was requested but unavailable: were the needle piece(s) retrieved during the same procedure? what instruments were used to grasp the needle? where was the needle grasped during use? what was the size of the broken needle fragment? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.On what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? please describe any medical/surgical intervention required for this suture event including dates and results.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?.

• Brand Name: VCL+ VIO 27IN 3-0 S/A SH
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23467898
• Report Number: 2210968-2025-12512
• Device Sequence Number: 8807667
• Product Code: GAM
• UDI-Device Identifier: 10705031052239
• UDI-Public: (01)10705031052239(17)300331(10)107RQC
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K132580
• 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): 11/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCP316H
• Device Lot Number: 107RQC
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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: Required Intervention
• Patient Sex: Unknown