MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP317H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
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 qjmkzs, and no non-conformances related to the reported complaint condition were identified 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.Note: event reported in 2210968-2021-04201 and 2210968-2021-04202.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 unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the needle detached from the suture.No additional information was provided.

• Brand Name: MCRYL+ VIO 27IN 2-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11768579
• Report Number: 2210968-2021-04201
• Device Sequence Number: 19941942
• Product Code: GAM
• UDI-Device Identifier: 10705031046375
• UDI-Public: 10705031046375
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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: MCP317H
• Device Catalogue Number: MCP317H
• Device Lot Number: QJMKZS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 05/04/2021
• Patient Sequence Number: 1