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

Catalog Number	J322H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a vaginal repair procedure on (b)(6) 2025 and suture was used.During the procedure, the needle was separated on the suture during a procedure and was able to be retrieved it.They want to ensure that this won't happen again.There were no patient adverse event.Device unknown availability for return.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) h3 investigation summary: the product was returned to ethicon for evaluation.One open box with thirty-one representative unopened samples, one empty open foil, two paper lids and two empty winding formers were received for analysis.Product code j322h.The sample complaint was not received for evaluation.Upon initial inspection of the samples, no external damage was evident to the exterior packaging.Following the sampling plan, a visual inspection was conducted on thirteen samples.The packets were opened, and swage and attachment areas appeared as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related.No defects were observed during evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.H6 component code: g07002 - no device problem found.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: when did the needle detach or pull off from the suture: detached inside the package, during removal from the package, during handling prior to use on the patient, or during use on the patient? during use on the patient did the needle fall inside the patient? if yes, was the needle piece(s) retrieved during the same procedure? what efforts were made to retrieve it? the needle was retrieved without incident.What is the procedure name and date? (b)(6) 2025 vaginal repair.Is this device or samples from the same lot available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number) yes, we have a box of the same lot # do you need the entire box back? please have the shipper kit send to my attention: (please refer to the attached mail), materials management manager, (please refer to the attached mail) please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager) combination of myself, (please refer to the attached mail).

• Brand Name: VCL CT BRD VIO 27IN 3-0 S/A MH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22985941
• Report Number: 2210968-2025-10229
• Device Sequence Number: 8972972
• Product Code: GAM
• UDI-Device Identifier: 10705031038783
• UDI-Public: (01)10705031038783(17)47330(10)UBBDXKX0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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: J322H
• Device Lot Number: UBBDXKX0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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