MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	X425H
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 4/8/2026.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: did the reported issue contribute to any patient adverse consequences? do you have any photos available for visual analysis? was the sterility of the device compromised? please describe the sterile packaging: were there any issues with the seal of the sterile packaging? are there any tears/holes in the sterile packaging? please provide the source or name of person providing answers to follow-up questions: h3 investigational summary: the product was returned to ethicon for evaluation.One empty open overwrap and one labeled winding former with an undispensed stand were received for analysis.Product code x425h.The visual assessment of the sample revealed dirt or black stains in the labeled winding former, which appears unrelated to the manufacturing process.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of the 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.It was reported there was black discoloration noted inside of package.Was not used for surgery.There were no patient consequences reported.Additional information was requested.

• Brand Name: ETHIBOND EXCEL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24816170
• Report Number: 2210968-2026-03691
• Device Sequence Number: 17678623
• Product Code: GAT
• UDI-Device Identifier: 10705031057296
• UDI-Public: (01)10705031057296(17)300630(10)109EC1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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

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: X425H
• Device Lot Number: 109EC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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