MAUDE Adverse Event Report: ETHICON INC. MONOCRYL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y943G
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
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.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 via: what is the current status of the patients? 1) patient needed revision surgery for dehiscence of body wall closure of a spay (the subq and skin layers remainder intact but were closed with a different suture, 3-0) 2) patient needed incision cultured and stapled after it dehisced 2 days after mass removal surgery 3) neuter patient returned for minor irritation of incision site but no intervention needed -has there been any suture breakage? 1) one of the knots came untied 2) suture appeared to have snapped in the center 3) n/a -do you have any photos available for visual analysis? please see attached - could you kindly perform and document the follow-up attempt for the product return? product name: mcryl vio 36in 2-0 s/a fs-1 product code: y943g lot number: 106zdz - please provide the source or name of person providing answers to follow-up questions (please refer to the mail).
Event or Problem Description
It was reported an animal underwent an unknown veterinary procedure in (b)(6) 2026 and suture was used.During the procedure, it was reported to the dl, per healthcare professional that the product was fraying and coming apart for 3 different patients and 3 different doctors.2 patients had the wounds come open 1 patient need er care.One patient is returning.Device is available for return.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: MONOCRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: 25092995
• Report Number: 2210968-2026-04934
• Device Sequence Number: 17352706
• Product Code: GAN
• UDI-Device Identifier: 10705031218635
• UDI-Public: (01)10705031218635(17)300228(10)106ZDZ
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: Y943G
• Device Lot Number: 106ZDZ
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2025
• 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