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

Catalog Number	9000G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Additional information was requested, and the following was obtained via: 1.Did the needle fall into the patient? no 2.If yes, was the needle piece(s) retrieved during the same procedure? what measures were implemented to retrieve the broken piece? 3.It was reported that "no one was injured but there is a potential injury possible".Were any patient consequences observed, or was the issue limited to a potential risk? no patient consequences were observed, it was only a potential.4.What is the procedure name and date? cataract surgery may 26th 2026 5.Please provide the source or title of external person providing answers to follow-up: jc (please refer to the attached email), asc materials assistant.
Event or Problem Description
It was reported that a patient underwent a cataract procedure in 2026 and suture was used.During the procedure, it was reported by distributor per account that customer stated two needles in the box broke in half when they tried to load it onto the needle holder.No one was injured but there is a potential injury possible.Device is not available for return.No adverse patient consequences were reported.Additional information was requested.

• 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: 25535695
• Report Number: 2210968-2026-06434
• Device Sequence Number: 13197540
• Product Code: GAR
• UDI-Device Identifier: 10705031022300
• UDI-Public: (01)10705031022300(17)301130(10)10CMMX
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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: 9000G
• Device Lot Number: 10CMMX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown