MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 3-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y942G
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.To date the device has not been returned.If the device or further details are received later a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, and the following was received: - what was the appearance of the suture after the wound dehiscence that occurred on the animal? please explain.---the suture was hanging out, knots were not intact at site of dehiscence.Skin was infected, inflamed with discharge at this location - did the suture break post-op? ----not sure - did the suture pull out of the tissue? ---yes.
Event or Problem Description
It was reported that an animal underwent mass removal procedure in 2024 and suture was used.During mass removal, the incision got infected and came apart.The suture was hanging out, knots were not intact at site of dehiscence.Skin was infected, inflamed with discharge at this location.The suture pulled out of the tissue.Additional information was requested.

• Brand Name: MCRYL VIO 36IN 3-0 S/A FS-1
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19981765
• Report Number: 2210968-2024-08486
• Device Sequence Number: 12797181
• Product Code: GAN
• UDI-Device Identifier: 10705031218642
• UDI-Public: (01)10705031218642(11)231129(17)281031(10)TMMPRB
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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: Y942G
• Device Lot Number: TMMPRB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• 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