MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y762H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.Attempts are being made to receive a device for evaluation.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted 2210968-2020-05304, 2210968-2020-05305, 2210968-2020-05307.
Event or Problem Description
It was reported that an animal underwent an animal surgery in 2020 and the suture was used.During the procedure, the needle came off of the suture mid stitch.

• Brand Name: MCRYL VIO 36IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10276481
• Report Number: 2210968-2020-05306
• Device Sequence Number: 2233949
• Product Code: GAN
• UDI-Device Identifier: 10705031059573
• UDI-Public: 10705031059573
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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: 12/31/2024
• Device Model Number: Y762H
• Device Catalogue Number: Y762H
• Device Lot Number: QAMJEP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1