MAUDE Adverse Event Report: Ethicon Inc. ETHILON; Suture, Nonabsorbable, Synthetic

Catalog Number	1662G
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.During surgery, it was found that there was a foreign matter in the sterilization package after opening the product.It was not a control release needle.The product was not used for the patient.Another product was used to complete the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: 1.Where was the foreign material found? inside the sterilization package.2.Please describe the type of foreign matter that was observed.The size was approximately 1mm.3.What was the foreign matter¿s appearance? black.4.Are there any photos of the foreign matter available? yes.5.Is it possible that the foreign material fell into packaging upon opening of device? no.6.Was the product seal on the foil still intact when the package was opened? yes.The following information was requested, but unavailable: 1.What was the texture? unk.H3 investigation summary: according to information received, during an unknown surgery a foreign matter was found inside the sterilization package after opening product code 1662g.The product was not used on the patient, another product was used to complete the case, and there were no adverse consequences to the patient.The product was returned to eth for evaluation.One sealed unopened sample was received for analysis.Product code 1662g.Overall review of the sample returned shows a black unknown foreign matter inside the overwrap packet.Additionally, four photographs were provided, clearly displaying the foreign matter, which is consistent with the condition of the sample received.Based on the information currently available, the foreign matter was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Device history review: a manufacturing record evaluation was performed for the finished device batch 10d9z6, 1662g-55 and no non-conformances were identified.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.

• 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 ; PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50755450
• Report Number: 2210968-2026-09133
• Device Sequence Number: 9241096
• Product Code: GAR
• UDI-Device Identifier: 10705031001701
• UDI-Public: (01)10705031001701(17)301231(10)10D9Z6
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 1662G
• Device Lot Number: 10D9Z6
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2026
• 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