MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 6-0 D/A S-14; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J570G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in (b)(6) 2025 and suture was used.It was reported that the suture was broken when the surgeon attempted to sew the tissue.Changed another one to continue the surgery, the same problem happened.Changed another one to complete the surgery.There is no report on patient's injury.Doctor reported that the batch of suture bodies no longer had the same toughness as before, and they often broke under the same force as before.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/30/2025.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested; the following was obtained: did the event occur during one or multiple patient procedures? what is the total number of procedures? --received information as following from sales rep via phone today.The event occurred during multiple patient procedures; the total number of procedures is unknown.1.(b)(4) was created to capture the ambiguous multiple event report the under (b)(4), note a-14354524: "received information as following from sales rep via phone today.The event occurred during multiple patient procedures; the total number of procedures is unknown.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 Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 2/18/2026.Additional information: h6.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.

• Brand Name: VCL CT BRD VIO 18IN 6-0 D/A S-14
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23926944
• Report Number: 2210968-2025-14706
• Device Sequence Number: 9012872
• Product Code: GAM
• UDI-Device Identifier: 10705031041318
• UDI-Public: (01)10705031041318(17)270430(10)1057CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: J570G
• Device Lot Number: 1057CH
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2024
• 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
• Patient Sex: Unknown