MAUDE Adverse Event Report: ETHICON INC. VCL UC MONO VIO 4IN 10-0 S/A CS140-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	V960G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/30/2025.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, 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: were there any adverse consequence associated with the patient? no adverse events however each episode happened whilst patient on operating table.When was the suture broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.Multiple episodes, during handling and use on the patient during one of the 3 episodes.How many devices demonstrated the alleged deficiency? x 4 sutures.Did the event occur during one or multiple patient procedures? multiple.What is the total number of procedures? 4.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).No.If this event occurred in multiple procedures, please create a product complaint for each event and provide the respective reference number(s).All were from same box same lot number.Please document the shipment tracking number: please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).(b)(6) please also provide us with an update with regards to the product return.Have you already returned the product for analysis? no, requested not to send until given the go ahead from j&j (if yes, please confirm the date shipped and the courier tracking number) if the hospital has not or will not release the product until a future date please confirm this and what the future date is.If the product is no longer available, please advise.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 single complaint was reported with multiple events.There are no additional details regarding the additional events.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture snapped immediately and broke.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 investigation summary: the product was returned to ethicon for evaluation.One open box with four unopened samples was received for analysis.Product code v960g.To evaluate the condition of the returned sample, the packets were opened.The swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along of the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.The functional test was performed using instron equipment and tensile force was above the minimum requirements.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.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information: h6, d9, h3.Corrected data: d1, d2a, d2b, d3, d4, h4 full udi.Product code and lot updated.

• Brand Name: VCL UC MONO VIO 4IN 10-0 S/A CS140-6
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21272957
• Report Number: 2210968-2025-01089
• Device Sequence Number: 11714800
• Product Code: GAM
• UDI-Device Identifier: 10705031051324
• UDI-Public: (01)10705031051324(17)281231(10)UAMLJR
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: V960G
• Device Lot Number: UAMLJR
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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