MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 48IN 3-0 S/A EN-S; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	D7795
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
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.During the procedure, it was reported that they had an issue with 3-0 vicryl en-s.Two reported incidents of the needle becoming detached from the suture after entering the 2nd time through the port.The needle was retrieved from the abdomen after it detached.Surgical delay unknown.One device is returning.There were no adverse reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint: (b)(4).H6 component code: g07002 - device evaluation pending 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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested, and the following was obtained via: it was reported that "¿two reported incidents of the needle becoming detached from the suture after entering." ¿ did the alleged deficiency occur over two different procedures? *if yes, - have any of these events been previously reported to ethicon? if yes, provide the respective reference number(s).- please create a new pc file for each patient/event.- were x-rays taken to locate the needle? - was the needle removed from the patient during the same procedure? - was there any additional tissue damage as a result of searching for the needle? - what measures were taken to retrieve the needle? - please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).All information available has been provided.The shipper has been sent with 1 each from the affected lot.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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.Additional information: h6, d9, h3, h4 h3 investigation summary: the product was returned to ethicon for evaluation.One unopened sample was received for analysis.Product code d7795.The complaint sample was not received for evaluation.Upon initial inspection of the sample, no external damages were observed on the external packet.In order to evaluate the condition of the returned sample, the packet was opened.The swage and attachment area were noted as expected.The suture was dispensed without problems and examined along the strand no anomalies were observed during the evaluation.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.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.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.

• Brand Name: VCL CT BRD VIO 48IN 3-0 S/A EN-S
• 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: 22105524
• Report Number: 2210968-2025-05972
• Device Sequence Number: 7023375
• Product Code: GAM
• UDI-Device Identifier: 10705031028449
• UDI-Public: (01)10705031028449(17)281031(10)TMMQJL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: D7795
• Device Lot Number: TMMQJL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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