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

Catalog Number	697G
Medical Device Problem Codes	Material Deformation (2976); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown plastic surgery procedure on (b)(6) 2026 and suture was used.It was reported, before an unknown plastic surgery, the issue was discovered when tried to use the product.Out of the entire box (containing 12 packages), two packs had already been opened.The plastic at the bottom was bent where the green stripe was cut, and the needle was pointing upwards.The same condition is visible from the outside on the remaining 10 packages.As the distribution agency has confirmed at hand that all products are bent, the product involved is reported the entire 12 packages.The product was not used for the patient.It was not a control release needle.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.
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.H6 component code: c22 - photo analysis.Additional information was requested, the following was obtained: - please describe the sterile packaging: - were there any issues with the seal of the sterile packaging? no.This issue is needle deformation.- are there any tears/holes in the sterile packaging? no - could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.Tracking number: (b)(6).- please provide the source or name of person providing answers to follow-up questions: (b)(4).The manufacturing record evaluation was performed for the finished device lot number and identified a ncr related to the reported incident.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The final quality release criteria were met before this batch was released for distribution.H3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one open box with ten (10) unopened samples were received for analysis.Product code 697g.In order to evaluate the condition of the returned samples, the packets were examined for visual defects: and no anomalies or defects were found on the overwrap packets.The packets were opened and the needles were removed from their trays, examination revealed that all needles exhibited bending at the body and swage area.Four photos were provided for analysis showing one tray apparently distorted for product code 697.Based on the information currently available, bending needles were identified during the investigation of the sample received.This product issue will be addressed through ethicon quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• 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.-San Lorenzo PR; road 183, km 8.3; san lorenzo PR 00754 ; PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50859075
• Report Number: 2210968-2026-09305
• Device Sequence Number: 9508754
• Product Code: GAR
• UDI-Device Identifier: 10705031008540
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Remedial Action: Recall
• Type of Report: Initial

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: 697G
• Device Lot Number: 10B3QS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2648650-09/22/2026-002-R
• Patient Sequence Number: 1
• Patient Sex: Unknown