MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 36IN(90CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number	F2415H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/5/2025.H6 component code: g07002 - device not returned.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 have been made to retrieve the device.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 an animal (female dog) underwent a mammectomy procedure in (b)(6) 2025 and suture was used.During skin suture, after two tissue passages and without exerting excessive pressure, the needle became detached from the thread.Another suture from the same batch was used: the needle pulled off under the same conditions after two or three passes through the skin.The surgery could be completed, using a new thread, without affecting the animal.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/24/2025.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.H6 component code: g07002 pending evaluation of returned device.Additional information: d9, h3, h6.A device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

• Brand Name: ETHILON SUTURE 36IN(90CM) 3-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• 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: 21962777
• Report Number: 2210968-2025-04902
• Device Sequence Number: 18441130
• Product Code: GAR
• UDI-Device Identifier: 10705031238930
• UDI-Public: (01)10705031238930(17)290630(10)1021T9
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: F2415H
• Device Lot Number: 1021T9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2024
• 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