MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 3-0 S/A CP-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z968H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an animal underwent an unknown procedure on an unknown date and suture was used.The suture had fallen apart and the animal experienced a wound dehiscence.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H6 component code: g07002 device not returned.D4: udi: as the catalog/model number was not provided, the (01)gtin is not available.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.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.Please clarify how many animals experienced a wound dehiscence.How many animals experienced a wound dehiscence that led to death? please provide the pds suture product code(s) and lot #(s) if available.Did the suture(s) break post operatively? if no, please explain.Please provide any additional relevant information if available.Will any actual device or unopened samples be returned for evaluation?.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Corrected information: d1, d4.Additional information: d4, g1, h4, h6.Additional information received: 3-0 pds in s.I.Pattern enterotomy.3-0 pds in sc pattern gastrotomy with cushing overlay.Subcuticular closure with 4-0 pds (sq was 3-0 pds).Riddle.5 days post-op, incision dehisced.Found that the enterotomy site had also dehisced.O elected humane euthanasia w/o waking pet from anesthesia.3-0 pds: ubmdhj, ref # (b)(4), exp 1/31/2029- pulled.3-0 pds: tgmhps, ref # (b)(4), exp 5/31/2028- pulled.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/20/2025.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.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PDSII VIO 27IN 3-0 S/A CP-2
• 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: 20452629
• Report Number: 2210968-2024-10754
• Device Sequence Number: 12523747
• Product Code: NEW
• UDI-Device Identifier: 10705031061934
• UDI-Public: (01)10705031061934(17)290131(10)UBMDHJ
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2024

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: Z968H
• Device Lot Number: UBMDHJ
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 04/23/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/06/2024; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• 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