MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 27IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP333H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).Date sent to the fda: 02/24/2020.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 that a patient underwent an unknown surgery on (b)(6) 2020 and the suture was used.It was reported that at the first penetration, the suture and the needle detached like a control release suture.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/16/2020.Additional information: d4, d10, h4, h6.Corrected information: d3, g1, g2.A manufacturing record evaluation was performed for the finished device pa6588 batch number, and no non-conformances were identified.Additional h3 investigation summary: it was reported performance pull off suture needle.An empty opened foil, a paper lid and a winding folder with a detached needle of product code mcp333, lot # pa6588 were received for evaluation.During the visual inspection of a detached needle body fluids and marks on body needle could be observed appear to be by use of a surgical instrument.No remnant suture was observed into the barrel hole and the suture was not received to determine the assignable cause.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, it could not be determined what may have caused the reported incident.

• Brand Name: MCRYL+ VIO 27IN 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: 9746619
• Report Number: 2210968-2020-01416
• Device Sequence Number: 1815137
• Product Code: GAM
• UDI-Device Identifier: 10705031046382
• UDI-Public: 10705031046382
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 12/31/2020
• Device Model Number: MCP333H
• Device Catalogue Number: MCP333H
• Device Lot Number: PA6588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/16/2020
• Patient Sequence Number: 1