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

Catalog Number	Y987H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pam110 batch number, and no non-conformances 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 a dog underwent an animal surgery on (b)(6) 2019 and the suture was used to close the incision.The suture had no defects that could be observed during the surgery.Then post-operatively, the suture was found to be broken down in incision.
Additional Manufacturer Narrative
(b)(4).Additional investigation summary: four unopened samples of product code y987, lot # pam110 were returned for analysis.The complaint sample was not received.During the visual inspection of four unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.

• 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: 9325658
• Report Number: 2210968-2019-89945
• Device Sequence Number: 419336
• Product Code: GAN
• UDI-Device Identifier: 10705031060005
• UDI-Public: 10705031060005
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 10/25/2019

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: Y987H
• Device Lot Number: PAM110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/06/2019
• Patient Sequence Number: 1