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

Model Number	Y346H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested, and the following was obtained: what are the procedure and event date? the exact dates are unfortunately unknown.They both did occur in the month of (b)(6), during what was believed to be during 2 spay surgeries.We have had the needles falling off the suture material, we have saved the 2 packages.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain 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.Can you please clarify if the needles separated from the suture during the actual procedure or pre-operatively during handling? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2022-03989.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that an animal underwent an unknown procedure on an unknown date and suture was used.The needle fell off of the suture.There were no patient consequences reported.Additional information was requested.

• Brand Name: MCRYL VIO 36IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14474700
• Report Number: 2210968-2022-03988
• Device Sequence Number: 5373243
• Product Code: GAN
• UDI-Device Identifier: 10705031058910
• UDI-Public: 10705031058910
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2022

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: 06/30/2026
• Device Model Number: Y346H
• Device Catalogue Number: Y346H
• Device Lot Number: RHMBKB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown