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

Catalog Number	1698G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H6 component code: g07002 device not returned.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.Additional information was requested, and the following was obtained: when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify during use on the patient.Is the product available to be returned for evaluation? if yes, to who and where can a return kit be send for recollection? no, all sharps are disposed of after the surgery is completed.We still have several sutures from the lots we've had trouble with, so if needed, we can save the needle/thread the next time it happens but please be aware the suture will be considered a biohazard.I would like to make mention of one thing.The majority of the sutures we are having issues with (needles popping off) are 6-0 nylon - this information was passed along to mckesson already.That information is below: 5-0 nylon (698g) lot 10b315 - so far only 1 suture from this lot has broken.6-0 nylon (1698g) lot 10bacd - at least 5 sutures from two different boxes from this lot have broken.6-0 nylon (1698g) lot 10c7k3 - 2 sutures from one box in this lot have broken.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture needle popped off the thread.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 5/13/2026.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: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• 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: 24939343
• Report Number: 2210968-2026-04310
• Device Sequence Number: 21495699
• Product Code: GAR
• UDI-Device Identifier: 10705031002180
• UDI-Public: (01)10705031002180(17)301031(10)10C7K3
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 1698G
• Device Lot Number: 10C7K3
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 05/03/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2025
• 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