MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP316H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: was there any change in the patient¿s post-operative care due to the prolonged procedure? no, there were no changes.In relation to needle, what is the approximate location of suture breakage? usually it was a few inches from the needle.Proximal to the needle.Did the sutures separate completely? yes, the sutures were completely separated.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.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m events reported via: 2210968-2021-07271, 2210968-2021-07272, 2210968-2021-07273, 2210968-2021-07274 and 2210968-2021-07275.
Event or Problem Description
It was reported that a patient underwent a gastric bypass procedure on (b)(6) 2021 and suture was used.During the procedure, the suture broke.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 10/04/2021 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, 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 batch, and no non-conformances were identified.

• Brand Name: MCRYL+ VIO 27IN 3-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12314128
• Report Number: 2210968-2021-07273
• Device Sequence Number: 3181612
• Product Code: GAM
• UDI-Device Identifier: 10705031046368
• UDI-Public: 10705031046368
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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: 06/30/2022
• Device Model Number: MCP316H
• Device Catalogue Number: MCP316H
• Device Lot Number: QHMHKM
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1