MAUDE Adverse Event Report: ETHICON INC. VCL MESH KNIT UD 6INX6IN; MESH, SURGICAL, POLYMERIC

Model Number	VKMM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Attempts are being 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.(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a hernia repair procedure on (b)(6) 2022 and mesh was used.The mesh was found to be torn into pieces when opened for use.The mesh was not used.The procedure was successfully completed and there were no adverse patient consequences reported.No further information was provided.
Additional Manufacturer Narrative
(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.Photo analysis summary: this is an analysis of the photo submitted to ethicon, inc.For evaluation.The photo shows several small pieces of mesh in a container that belong to product code vkmm.No conclusion or root cause could be determined.Please refer to the previously submitted device analysis for full analysis details and conclusion.As part of the ethicon, inc.Quality process, all devices are manufactured, inspected, and released to approved specifications.
Additional Manufacturer Narrative
(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.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that several small mesh pieces into a bag that pertain to product code vkmm were returned for analysis.Upon visual assessment of the mesh pieces, it was observed that the mesh had begun with a degradation process caused by exposure to the environment and functional test cannot be performed.The packaging was not received for evaluation to determine the cause.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: VCL MESH KNIT UD 6INX6IN
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15923921
• Report Number: 2210968-2022-09996
• Device Sequence Number: 6793874
• Product Code: FTL
• UDI-Device Identifier: 10705031056923
• UDI-Public: 10705031056923
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K810428
• 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,Followup
• Report Date (Section B): 12/06/2022

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 Expiration Date: 09/30/2023
• Device Model Number: VKMM
• Device Catalogue Number: VKMM
• Device Lot Number: ML7066
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 01/17/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/17/2023; 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2018
• 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