MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 5-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J463G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
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.Additional information was requested, and the following was obtained via: * is this device or samples from the same lot available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number) yes, we do still have the patrial box and the full unopened box with the same lot number here in hospital.The shipper kit can be sent to hospital manager, email and phone number is see attached email.* please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) external person is sd, inventory manager * 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.Has not been shipped yet, haven't received shipping label for return yet.
Event or Problem Description
It was reported an animal underwent an unknown veterinary procedure on (b)(6)2024 and suture was used.During the procedure, it was reported by the distributor per customer that the 3 have been used from one box, needle tip breaking off, product defective (clinic wants to return 2 boxes).There was no patient consequences.The device is available for return.No adverse patient consequences were reported.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 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 was requested, and the following was obtained: ¿ can you please clarify if the device(s) are still available for evaluation? yes they are still available ¿ if yes, please clarify how many products are available to be returned and to who and where can a return kit be send for recollection? i have one opened box with approximately 3 missing and one unopened box.A return kit can be sent *address provided.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 3/12/2025.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.Additional information.H3 investigational summary: the product was returned to ethicon for evaluation.One sealed box with twelve representative unopened samples and one open box with two representative unopened samples were received for analysis.Upon initial inspection of the samples, no external damages were observed on the external packets.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened, and the swage and attachment area were noted to be as expected.The tip and body of the needles were examined under magnification and no defects or needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.As part of 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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL CT BRD VIO 18IN 5-0 S/A P-3 PRM MP
• 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: 20914008
• Report Number: 2210968-2024-13324
• Device Sequence Number: 20789720
• Product Code: GAM
• UDI-Device Identifier: 10705031040137
• UDI-Public: (01)10705031040137(17)290731(10)102MAL
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

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: J463G
• Device Lot Number: 102MAL
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 01/20/2025; 02/13/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/30/2025; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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