MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 36IN 3-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP923G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 number qjmejd /mcp923g, and no non-conformances related to the reported complaint condition were identified.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.
Event or Problem Description
It was reported that an animal underwent an orthopedic procedure on an unknown date and suture was used.The suture broke when pulling the skin together.No further information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 03/08/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Additional h6 component code: g07002 device not returned.

• Brand Name: MCRYL+ VIO 36IN 3-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11415548
• Report Number: 2210968-2021-01986
• Device Sequence Number: 11608613
• Product Code: GAM
• UDI-Device Identifier: 10705031218611
• UDI-Public: 10705031218611
• Combination Product (Y/N): Y
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 07/31/2022
• Device Model Number: MCP923G
• Device Catalogue Number: MCP923G
• Device Lot Number: QJMEJD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1