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

Catalog Number	Z451G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an animal underwent an unknown veterinary procedure on an unknown date and suture was used.Post-op, it was reported by healthcare professional that they had a bit of a near disaster, dr removed a mass and when the dog was set to go home the incision actually let go, when dr went in to find out what was happening, dr found that the suture had actually been in pieces, like it had disintegrated.He used most of the box on prior surgeries and they are bit apprehensive about this happening again.The reason this concerns is because this happened many many years ago to another dr, it was a cassett, several of them, it left a bad taste in their mouth.It happened when the dog was still here and is doing very well at home now.Device availability is unknown.No adverse patient consequences were reported.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.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 via: it was reported the same issue happened many years ago, how many devices demonstrated the alleged deficiency? this was at least 20 years ago not ethicon.Did the event occur during one or multiple patient procedures? this event was the one reported.What is the total number of procedures? 1.Have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? no.Could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided i can return the 2 that are left, where am i returning them to? please provide the source or name of person providing answers to follow-up questions: (please refer to the attached mail).
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: b1, h1 - this medwatch report is being voided.Based on additional information received, the previously reported event did not involve ethicon/j&j sutures/product.

• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23316594
• Report Number: 2210968-2025-11970
• Device Sequence Number: 4967293
• Product Code: NEW
• UDI-Device Identifier: 10705031218697
• UDI-Public: (01)10705031218697(17)291231(10)1063X6
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 1063X6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/20/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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