MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 4-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y315H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the 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.Events were submitted via 2210968-2020-03628 and 2210968-2020-03629.
Event or Problem Description
It was reported by vet that an animal underwent an oral animal surgery in 2020 and the suture was used.During the procedure, the needle popped off of the suture.It was also reported that the needle was retrieved and accounted prior to finishing the surgical procedure.Another like suture was used to complete the procedure successfully.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Corrected information: - no device returned.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 4-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10011795
• Report Number: 2210968-2020-03629
• Device Sequence Number: 2077996
• Product Code: GAN
• UDI-Device Identifier: 10705031058729
• UDI-Public: 10705031058729
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2020

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 Expiration Date: 05/31/2024
• Device Model Number: Y315H
• Device Catalogue Number: Y315H
• Device Lot Number: PG6799
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 05/01/2020; 05/01/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/05/2020; 05/06/2020
• Patient Sequence Number: 1