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

Model Number	MCP317H
Medical Device Problem Codes	Material Separation (1562); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an animal underwent a unknown procedure on an unknown date and suture was used.During the procedure, the suture became detached from the needle as well as experienced difficulty removing the suture from the dispenser.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: i sent a picture of the recent box we have had problems with, but it has been noticeable for the last year.There have been no patients affected by this, it is just a waste of our money.I would estimate that one out of every 3-4 packs of 2-0 monocryl plus in the last year do not dispense properly.Maybe 1 in 10 pop off of the needle.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.Related to: 2210968-2022-00781, 2210968-2022-00783, 2210968-2022-00784.
Additional Manufacturer Narrative
Product complaint number: (b)(4).Date sent to the fda: 4/26/2022.H6 component code: g07002 - device not returned.H6 component code: c22 - photo analysis.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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 information: h6 a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.H3 investigational summary - c22 photo analysis: visual analysis of the image submitted to for evaluation determined that an open case of product code mcp317h could be observed the image is not clear to determine the failure mode.As part of our quality process, the manufacturing records for this lot serial number were reviewed and manufacturing standards were met prior to the release of this lot.No conclusion could be reached as to the cause of the reported complaint as the sample was not returned for analysis.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure it meets required specifications prior to shipment.Additional monitoring of complaint information for potential safety signals is conducted through complaint trends as part of post-market surveillance.Trade name - irgacare.Active ingredient(s)- triclosan.Dosage form - suture/solid/parenteral.Strength - = 2360 g /m.

• 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
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13420099
• Report Number: 2210968-2022-00782
• Device Sequence Number: 11975375
• Product Code: GAM
• UDI-Device Identifier: 10705031046375
• UDI-Public: 10705031046375
• Combination Product (Y/N): Y
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 06/30/2023
• Device Model Number: MCP317H
• Device Catalogue Number: MCP317H
• Device Lot Number: RHMKCC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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