MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 3-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J311H
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506); Defective Component (2292); Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.
Event or Problem Description
It was reported that a patient underwent a thoracoscopic malignant tumor resection procedure on (b)(6) 2025 and suture was used.During the procedure, it was reported by a sales rep that during the surgery using multiple sutures, the sutures and needles of the two products involved were noticeably thinner than usual, and a suture breakage had occurred.Additional sutures from another package were used to complete the surgery, but the doctor has questions about the quality.It was not a control release needle.Another product was used to complete the case.Further details are not provided from the hp.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/28/2025.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.H6 component code: g07002 no device problem found.Corrected information: d4 udi.Additional information: d9, h3, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Four unopened foil packets and one unused needle suture combination outside the packaging were received for analysis.Product code j311h.During the visual inspection of the needle suture, the swage and attachment area were noted to be as expected.The needle and suture were examined, and no anomalies could be observed.To evaluate the condition of four unopened samples, the packets were opened.The needles and sutures were examined and a difference in the diameter could be observed in two samples.In further investigation, the needles were examined and the were noted to be the corresponding taper point needle for the j311h product code.However, it was found that two needle did not conform to diameter needle requirement due to they were over-polished.The functional test was performed in the four sutures using instron equipment and the tensile force was above the minimum requirements.Based on the information currently available, over polished 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 used needle suture piece and one empty winding former were received for analysis.During the visual inspection of the returned sample, body fluids were found on the needle and suture.The swage area and body needle were noted to be as expected.The suture was observed to be cut likely caused by a surgical instrument.Based on the current condition of the returned sample the functional test could not be performed, and it is not possible to definitively determine the root cause of the reported event.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached on the cause of the reported event.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL CT BRD VIO 27IN 3-0 S/A SH-1
• Common Device Name: SUTURE, ABSORBABLE, 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: 23224505
• Report Number: 2210968-2025-11428
• Device Sequence Number: 21197053
• Product Code: GAM
• UDI-Device Identifier: 10705031038691
• UDI-Public: (01)10705031038691(17)300228(10)106RR8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 10/06/2025

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: J311H
• Device Lot Number: 106RR8
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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