MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 3-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J311H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6)2026 and suture was used.The suture thread with the following description of what happened: "needle broke from the thread at the moment the subcutaneous was being closed, thread came out of the tissue and the needle remained.The needle was removed from the cavity during the initial procedure without harm to the patient.There was no change in the patient's condition due to this episode.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) additional information d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information provided: 3-0 27in coated vicryl vio - j311h (j311h list all j&j products that were used during the case but did not contribute to the reported event.Was there any damage or loss reported by the patient or user? no was there a significant delay? no additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.The needle was removed from the cavity during the initial procedure without harm to the patient.There was no change in the patient's condition due to this episode.The device is not available for return as it has been discarded.No product is available for return.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/25/2026 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.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: VCL CT BRD VIO 27IN 3-0 S/A SH-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24415532
• Report Number: 2210968-2026-01870
• Device Sequence Number: 10527120
• Product Code: GAM
• UDI-Device Identifier: 10705031038691
• UDI-Public: (01)10705031038691(17)300630(10)AW8210
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: J311H
• Device Lot Number: AW8210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/01/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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
• Patient Age: 10 YR
• Patient Sex: Unknown