MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 3-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y942G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to receive a device.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please explain what does it mean by ¿could not find the cranial aspect of the knot¿.Please clarify how the suture was tied during initial surgery (b)(6) 2021? could you please provide the lot number? please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.
Event or Problem Description
It was reported by vet that a cat underwent an ovariectomy/animal surgery on (b)(6) 2021 and the suture was used.Additional midline simple interrupted suture was also performed.On (b)(6) 2021, a vet described the linea suture as "ruptured" and was not able to find the fragment from the simple interrupted suture.It appeared to be a single strand of suture material, and could not find the cranial aspect of the knot.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 07/23/2021.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 inc, 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 was requested and the following was obtained: please explain what does it mean by ¿could not find the cranial aspect of the knot¿.I communicated with the veterinarian who performed gigi's hernia repair and they had stated they could not find evidence of a cranial knot (suggesting the knot was not intact).They report finding one long strand of monocryl that was firmly anchored to the knot of the caudal aspect of the incision.They were not able to find a fragment associated with the simple square knot that was also secured on the linea at the time of the initial spay.Please clarify how the suture was tied during initial surgery (b)(6) 2021? the linea was closed using 3-0 monocryl in a simple continuous pattern.Each knot (cranial and caudal aspect of simple continuous pattern) were secured using surgeon's knots with 4 additional throws.An additional simple square knot was placed midline on the linea for additional linea strength (routinely performed to prevent dehiscence or herniation).Could you please provide the lot number? qpmaxk.Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Suture from linea was not saved.

• Brand Name: MCRYL VIO 36IN 3-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11971516
• Report Number: 2210968-2021-05404
• Device Sequence Number: 4269444
• Product Code: GAN
• UDI-Device Identifier: 10705031218642
• UDI-Public: 10705031218642
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960653
• 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): 05/12/2021

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: 11/30/2025
• Device Model Number: Y942G
• Device Catalogue Number: Y942G
• Device Lot Number: QPMAXK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1