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	10/01/2021
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.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 (b)(4) investigation summary: an opened box with six packets of product code mcp923g was returned to ethicon inc for analysis with the packaging closed.Upon initial inspection of the samples, no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, the six packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to damaged or breakage sutures and no defects were observed during evaluation.Functional test was performed, and the tensile strength result was above the minimum requirements.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 information was requested and the following was obtained: did the surgery was completed successfully? if yes what was used to complete the procedure? surgery was completed successfully using monocryl from different box ¿ trade name - irgacare® ¿ active ingredient(s) ¿ triclosan ¿ dosage form ¿ suture/solid/parenteral ¿ strength ¿ = 2360 ug/m note: event reported in 2210968-2021-10408 and 2210968-2021-10409.
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 suture was breaking easily.There were no adverse patient consequences reported.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.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12704425
• Report Number: 2210968-2021-10408
• Device Sequence Number: 4641133
• Product Code: GAM
• UDI-Device Identifier: 10705031218611
• UDI-Public: 10705031218611
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 10/27/2021

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: MCP923G
• Device Catalogue Number: MCP923G
• Device Lot Number: QJMEJD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/27/2021
• Patient Sequence Number: 1