MAUDE Adverse Event Report: ETHICON INC. ETHLN BLK 18IN 3-0 S/A PS-1 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	1663G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiovascular procedure on (b)(6) 2025 and suture was used.During surgery, the suture was detached from the needle.It occurred with 3 packs in a row.Another product was used to complete the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) h6.Component code: g07002 - device not returned.Attempts have been made to retrieve the device.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.The following information was requested, but unavailable: when were the sutures detached from the needle (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify unk.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/26/2025.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: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.Two unopened samples that pertain to product code 1663 were received for analysis.To evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were not as expected, since the hit of the stake was on the edge of the swage area of the needles.In addition, the suture was examined, and no anomalies could be observed during the evaluation.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.Based on the information currently available, an incorrect swage issue was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Additional h3 investigational summary: the product was returned to ethicon for evaluation.One needle and one empty labeled winding former that pertain to product code 1663 were received for analysis.After investigation of the sample, the swage and attachment area were not as expected, since the stake hit was on the edge of the swage area of the needle.The barrel hole was examined and remnat suture was observed.The suture was not returned for evaluation.Based on the information currently available, an incorrect swage issue was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: ETHLN BLK 18IN 3-0 S/A PS-1 PRM MP
• 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: 22358826
• Report Number: 2210968-2025-07631
• Device Sequence Number: 8586702
• Product Code: GAR
• UDI-Device Identifier: 10705031001725
• UDI-Public: (01)10705031001725(17)291031(10)104LC2
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 06/30/2025

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: 1663G
• Device Lot Number: 104LC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2024
• 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