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

Model Number	Y334H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.An opened box with unopened samples of product were returned for analysis.During the visual inspection of thirteen 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 the strand with no defects, damage or suture breakage 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 samples received, no suture breakage was found and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that an animal underwent an animal surgery on an unknown date and a suture was used.During surgery, the suture breaks when pulling on needle.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 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: 9699944
• Report Number: 2210968-2020-01130
• Device Sequence Number: 2422514
• Product Code: GAN
• UDI-Device Identifier: 10705031058811
• UDI-Public: 10705031058811
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: 02/29/2024
• Device Model Number: Y334H
• Device Catalogue Number: Y334H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1