MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y345H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts have been made to retrieve the device.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The thread came of the needle during use.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 04/17/2020.Additional information: d4, h4 - the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch phk078; mfg date: 7/24/2019, exp date: 6/30/2021.Batch pc6689 ;mfg date: 3/19/2019, exp date:12/28/2021.A manufacturing record evaluation was performed for the finished device phk078 possible batch number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device pc6689 possible batch number, and no non-conformances were identified.Additional h3 investigation summary: it was received for analysis an opened box with unopened samples of product code mcp4260, lot phk078.During the visual inspection of the 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 strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.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, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.It was received for analysis an opened box with unopened samples of product code mcp4260, lot pc6689.During the visual inspection of the 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 strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.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, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 2-0 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: 9455022
• Report Number: 2210968-2019-90783
• Device Sequence Number: 19355304
• Product Code: GAN
• UDI-Device Identifier: 10705031058897
• UDI-Public: 10705031058897
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K960653
• 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): 11/20/2019

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 Model Number: Y345H
• Device Catalogue Number: Y345H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 04/17/2020
• Patient Sequence Number: 1