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, 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: events reported in 2210968-2021-02121, 2210968-2021-02122, 2210968-2021-02124, and 2210968-2021-02125.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.
Event or Problem Description
It was reported that a dog underwent a neuter procedure on an unknown date and suture was used.During the procedure, the suture broke with the normal tension.No additional information was provided.

• 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: 11440946
• Report Number: 2210968-2021-02123
• Device Sequence Number: 4611315
• 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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1