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

Catalog Number	Y344H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device paz278 number, and no non-conformances were identified.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: please provide total number of procedures with the suture breakage issues with devices from this box.Were all procedures reported to ethicon? if yes, please provide pc numbers.If no, please provide events dates,quantity involved in each procedure accordingly.Answers: three procedures.Do not have dates, one package for each procedure.Note: events reported via medwatch 2210968-2019-85620, 2210968-2019-85621, 2210968-2019-85622.
Event or Problem Description
It was reported that an animal underwent an unknown procedure on an unknown date and suture was used.The suture was breaking when trying to tie the knot.It is unknown how the procedure was completed.

• Brand Name: MCRYL VIO 36IN 3-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8897656
• Report Number: 2210968-2019-85622
• Device Sequence Number: 16520195
• Product Code: GAN
• UDI-Device Identifier: 10705031058880
• UDI-Public: 10705031058880
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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: 12/31/2023
• Device Catalogue Number: Y344H
• Device Lot Number: PAZ278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/15/2019
• Patient Sequence Number: 1