MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	669H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.The needle breaks out of the thread when sewing and knotting.There was no delay and the procedure was successfully completed without fragments generated.There were no adverse patient consequences.No further information was provided.
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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.H6 component code: g07002 ¿ no device problem found.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.The following information was requested, the following was obtained: product code: 669h.Product lot #/batch: 107tpd.Tracking #: (b)(4).Received at cg labs on 10/2/1025.1.Could you please clarify if extra device belongs to this complaint? 2.If not, could you please clarify if the extra received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.Yes, it belongs to the complaint.H3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one unopened sample that pertains to product code 669h was received for analysis.Upon visual inspection of returned sample, no external damages were observed on the packet.The packet was opened; the swage and attachment area were note to be as expected.The suture was dispensed without problems and no anomalies were noted along the suture strand.Functional testing using instron equipment showed that the pull force results were above the minimum requirements, and the device performed without any defect noted.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Based on the results of this investigation , it was determined that the product met the manufacturing release criteria: since no malfunction was observed during the investigation.No corrective and preventive action (capa) is required now.Investigation summary (local language).

• Brand Name: ETHILON SUTURE 30"(75CM) 3-0 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23756853
• Report Number: 2210968-2025-13773
• Device Sequence Number: 21315698
• Product Code: GAR
• UDI-Device Identifier: 10705031007918
• UDI-Public: (01)10705031007918(17)300331(10)107TPD
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 12/09/2025

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 Catalogue Number: 669H
• Device Lot Number: 107TPD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2025
• 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