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

Catalog Number	1663H
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2026 and suture was used.During the procedure, upon unpacking, the tip of the needle is blunt and seemed to be black.No adverse patient consequences were reported.Additional information was requested.
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, 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.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.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.Did the reported issue contribute to any patient adverse consequences? do you have any photos available for visual analysis? please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? what was the texture? was the product seal on the foil still intact when the package was opened? - will the device be returned for evaluation? if yes please return all relevant packaging material was the procedure completed without any adverse effect to the patient? please provide the source or name of person providing answers to follow-up questions: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional h11: ethln blk 18in 3-0 s/a ps-1 prm mp (1663h): side affected: not applicable ## reason product is not available: discarded.Ethln blk 18in 3-0 s/a ps-1 prm mp (1663h) : lot/batch number: 1073uz.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? ## unknown *** was there a significant delay? unknown if available, provide the product order number (po).

• 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: 25176273
• Report Number: 2210968-2026-05336
• Device Sequence Number: 21451105
• Product Code: GAR
• UDI-Device Identifier: 10705031001732
• UDI-Public: (01)10705031001732(17)300228(10)1073UZ
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2026

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: 1663H
• Device Lot Number: 1073UZ
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 06/05/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/03/2026; 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown