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.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.Note: events reported in 2210968-2021-02126.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 cat underwent a spay procedure on an unknown date and suture was used.During the procedure, the suture broke with the normal tension.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) date sent to the fda: 4/12/2021 h6 component code: g07002 - no device problem found.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, d9 additional h3 investigation summary : the product was returned for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.Visual analysis of the returned sample determined that one unopened sample of product code mcp923 was received for evaluation.Visual inspection of the unopened sample and no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along the strand and no defects, damage, or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.¿ trade name - irgacare® ¿ active ingredient(s) ¿ triclosan ¿ dosage form ¿ suture/solid/parenteral ¿ strength ¿ = 2360 ¿g/m corrected information: d3.

• Brand Name: MCRYL+ VIO 36IN 3-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11440994
• Report Number: 2210968-2021-02127
• Device Sequence Number: 4611317
• 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?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/12/2021
• Patient Sequence Number: 1