MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A FS-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z451G
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an animal underwent an unknown veterinary procedure on (b)(6) 2025 and suture was used.Post-op on (b)(6) 2025, it was reported by distributor that per clinic two cat spays they did the week of (b)(6) had their abdominal contents herniate out of the abdomen.The surgery was done by a decades long experienced vet who does surgery all the time.They used this suture to tie off the ovaries and close the abdominal wall.The device is available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = >(b)(4).H6 component code: g07002 - device not returned 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: cat 1: please provide information requested below for each event.- did the suture break post-op? yes, cat presented doa 3 days after surgery with complete dehiscence of abdomen contents.- did the suture pull out of the tissue? yes 2/0 pds suture was used to close the abdomen wall.- was any quality deficiency/non-conformance noted with the suture before use or during use? no - is this device or samples available for product analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number).(please refer the attached email) - please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) (please refer the attached email) cat 2: please provide information requested below for each event.- did the suture break post-op? yes, cat presented 7 days after surgery with a lump under the skin layer.Put under anesthesia and the abdominal wall had let go.- did the suture pull out of the tissue? yes 2/0 pds suture was used to close the abdomen wall.- was any quality deficiency/non-conformance noted with the suture before use or during use? no - is this device or samples available for product analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number).(please refer the attached email) - please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).

• Brand Name: PDSII VIO 27IN 2-0 S/A FS-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21699172
• Report Number: 2210968-2025-03188
• Device Sequence Number: 9308493
• Product Code: NEW
• UDI-Device Identifier: 10705031218697
• UDI-Public: (01)10705031218697(17)1/31/2029(10)UBMDRS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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 Catalogue Number: Z451G
• Device Lot Number: UBMDRS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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