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

Catalog Number	1696G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
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.The patient suffered a facial injury.During the process of suturing the patient's facial epidermis, the physician opened the suture and found that the problem of pulling off suture needle had happened.The doctor immediately replaced the suture with a new one and continued suturing.Prolonging the suturing surgery time brought unpredictable risks.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.The following information was requested, but unavailable: --received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.- how long was the delay? please specify in minutes.- were there any unexpected outcomes or complications as a result of the prolonged surgery time? - did this event contribute to any patient adverse event? if yes, please explain.- please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device 109j0z / 1696g batch number, and no non-conformances were identified.Expiration date: jun/30/2030 date of mfg.: jul/08/2025.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Device history review: a manufacturing record evaluation was performed for the finished device 109j0z / 1696g batch number, and no non-conformances were identified.Expiration date: jun/30/2030 date of mfg.: jul/08/2025.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.

• 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.-Juarez; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50751971
• Report Number: 2210968-2026-09107
• Device Sequence Number: 15763213
• Product Code: GAR
• UDI-Device Identifier: 10705031002159
• UDI-Public: (01)10705031002159(17)300630(10)109J0Z
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,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: 1696G
• Device Lot Number: 109J0Z
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2025
• 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