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	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).Device not returned.Additional information was requested and the following was obtained: could you please confirm how many devices presented this issue (suture breakage)? 3 packages of suture from the same box presented this issue.What was being done when the suture broke (e.G.Removal from package, during passage through tissue, during tying, post-op, etc.)? the suture was being used during a spay in surgery to tie off the uterus.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the reported complaint condition were identified.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.Trade name - irgacare¿.Active ingredient(s)  triclosan.Dosage form  suture/solid/parenteral.Strength  2360 g/m.Events reported via: (b)(4).
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 broke.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/15/2021.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.H3 evaluation: 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 samples determined that seven unopened samples of product code mcp923g were received for evaluation.Visual inspection of the unopened samples, the swage, and attachment area were noted to be as expected.The sutures were 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.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.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: 11548045
• Report Number: 2210968-2021-02623
• Device Sequence Number: 14476140
• Product Code: GAM
• UDI-Device Identifier: 10705031218611
• UDI-Public: 10705031218611
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 10/31/2022
• Device Model Number: MCP923G
• Device Catalogue Number: MCP923G
• Device Lot Number: QMMJBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/15/2021
• Patient Sequence Number: 1