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	05/03/2021
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.Product lot number? would be any sample available for return?.
Event or Problem Description
It was reported by vet that a cat underwent a ovariectomy procedure on (b)(6) 2021 and the suture was used.After the surgery, on (b)(6) 2021, with the overlying skin closure appearing intact and normal, a surgeon could not able to find the fragment from the simple interrupted suture.Additional information has been 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: product lot number? qpmaxk.Would be any sample available for return? 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: 11971146
• Report Number: 2210968-2021-05399
• Device Sequence Number: 4269440
• 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,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: 05/12/2021; 06/28/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 06/09/2021; 07/23/2021
• Patient Sequence Number: 1