MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y967H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mbm180 batch number, and no non-conformance's were identified.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.
Event or Problem Description
It was reported by vet that the animal underwent an animal c-section surgery on (b)(6) 2019 and the suture was used on the abdominal wall of the canine, using an interrupted loop.On (b)(6) 2019, the suture found to be broken 2/3 way of continuous line; knots were intact.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 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: 9349468
• Report Number: 2210968-2019-90151
• Device Sequence Number: 13505055
• Product Code: GAN
• UDI-Device Identifier: 10705031059993
• UDI-Public: 10705031059993
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/30/2019

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: 01/31/2023
• Device Catalogue Number: Y967H
• Device Lot Number: MBM180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1