MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18"(45CM) 4-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	662G
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/16/2025 h6 component code: g07002 - device not returned.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.Additional information was requested, the following was obtained: 1.Initial reported mention 12 devices involves, please clarify how many sutures degrade or break during this single procedure 2.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.3.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) they reported about 12 devices that involved.Some of them were thrown away and the others were given to us, and we sent them for investigation.Communication attached.The following information was received: was surgery delayed due to the reported event? --> no, action taken when event occurred? --> suture replacement, was procedure successfully completed? --> yes, were fragments generated? --> no, if yes, were they removed easily without additional intervention? --> unknown, if no, explain: --> no fragments, patient status/ outcome / consequences --> no, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> no, is the patient part of a clinical study --> no, ip-02382403 device property of -->none, device in possession of -->none.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.
Event or Problem Description
It was reported that a patient underwent an skin closure procedure on (b)(6) 2025 and suture was used.It was reported as the surgeon was using the sutures he noticed that the sutures began to change color and appeared to degrade or break more easily than expected.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/10/2025.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.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: ETHILON SUTURE 18"(45CM) 4-0 BLK
• 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22037460
• Report Number: 2210968-2025-05455
• Device Sequence Number: 8492886
• Product Code: GAR
• UDI-Device Identifier: 10705031007734
• UDI-Public: (01)10705031007734(17)260831(10)RKBBTU
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 662G
• Device Lot Number: RKBBTU
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2021
• 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