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

Catalog Number	9000G
Medical Device Problem Codes	Break (1069); Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
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 an unspecified eye procedure, surgeons experienced issues with the sutures.The surgeons complained that the sutures were not only snapping but also bending during use.They also felt that the sutures did not appear to be as sharp as normal, which caused difficulty during suturing.Due to these issues, the surgeons had to carefully remove the broken suture and proceed with another suture to complete the procedure, doing so at a much slower pace.No additional information provided.Devices will be returning for evaluation.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/27/2026 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.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: for the event in (b)(6) , 2026: * if possible, could you please confirm the quantity of sutures that broke and the quantity of needles that bent during this procedure? * were there any patient consequences? * please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.* please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).

• 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 ; 3035526892
• MDR Report Key: 25001341
• Report Number: 2210968-2026-04527
• Device Sequence Number: 9034184
• Product Code: GAR
• UDI-Device Identifier: 10705031022300
• UDI-Public: (01)10705031022300(17)300930(10)10BSA2
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 9000G
• Device Lot Number: 10BSA2
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2025
• 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