MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 5-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y303H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an animal underwent an unknown surgery on (b)(6) 2021 and suture was used.During the procedure, the needle pops off the suture material.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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: was there any quality deficiency/ non-conformance noted with the device before use or during possible re-operation? the product still worked as per normal for the time the needle was attached to the suture material.It was not tampered with prior to using.We have no had the same issue since then with the same box of suture.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported in 2210968-2021-09887, 2210968-2021-09888 and 2210968-2021-09889.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 5-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12656312
• Report Number: 2210968-2021-09887
• Device Sequence Number: 4852402
• Product Code: GAN
• UDI-Device Identifier: 10705031058675
• UDI-Public: 10705031058675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: No Information
• Device Expiration Date: 08/31/2025
• Device Model Number: Y303H
• Device Catalogue Number: Y303H
• Device Lot Number: QKMHJD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1