MAUDE Adverse Event Report: ETHICON INC. ETHILON; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1865G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 3/24/2026.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 there any patient consequences or unexpected complication due to the prolonged procedure? please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).The following information was reported: ethln blk 18in 5-0 s/a pc-3 prm mp (1865g) : both sides.Ethln blk 18in 5-0 s/a pc-3 prm mp (1865g) : ethln blk 18in 5-0 s/a pc-3 prm mp (1865g) : both sides.Ethln blk 18in 5-0 s/a pc-3 prm mp (1865g) : lot/batch number: list any j&j products that were utilized during the case but did not contribute to the reported event.Was there any reported patient or user harm? no.Was there a significant delay? yes.How long was the delay (minutes)? 5.If available, provide the product order number (po).Ethln blk 18in 5-0 s/a pc-3 prm mp - 1865g.Is the actual device with the alleged product quality issue being returned for analysis? or is an alternative device being returned? please specify.Ethln blk 18in 5-0 s/a pc-3 prm mp - 1865g.What is the unique device identifier? is the actual device with the alleged product quality issue being returned for analysis? or is an alternative device being returned? please specify another piece in the same lot will return because during case that found the problem already contaminated.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(4) 2026 and suture was used.The suture found problems during use; it kept coming loose from the needle while sewing.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/30/2026.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.H6 component code: g07002 no device problem found.H6 component code: c22 - photo analysis.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 photo summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show closed three-unit packages with 1865 product codes, the lot number 10981s, expiration date 2030-05-31.And in a second image two closed packages of the same product code, different batch number 10a6t9.The image is not clear to determine the failure mode or the reported condition.As the device was not returned, an analysis investigation could not be performed.Based on the photo review, the event reported is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: ETHILON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24694360
• Report Number: 2210968-2026-03075
• Device Sequence Number: 21449440
• Product Code: GAR
• UDI-Device Identifier: 10705031002838
• UDI-Public: (01)10705031002838(17)300531(10)10981S
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 1865G
• Device Lot Number: 10981S
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2025
• 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 Sex: Unknown