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)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: (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 april, 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.I do not have the exact dates unfortunately.They both did occur in the month of april.I believe that they were during 2 spay surgeries.We have the faulty packaging.Additional information received via (b)(4) stating: response received from hcp: that is correct we have had the needles falling off the suture material, we have saved the 2 packages.Both packages came from the same box.If you have any additional questions please let me know.I can be reached at 815-933-8831.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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, 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.
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; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14518262
• Report Number: 2210968-2022-04104
• Device Sequence Number: 5502876
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2022

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: 05/02/2022
• Initial Report FDA Received Date: 05/26/2022
• 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
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown