MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8975H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.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 a cardiovascular surgery on (b)(6) 2020, and suture was used.During the procedure, the suture broke.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: 11/16/2020 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 evaluation: an opened box with unopened samples of product were received for evaluation.During the visual inspection of unopened samples, no defects were found on the package.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 and no defects, damage or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.The device performed without any defect noted and the actual complaint sample was not returned for analysis.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PROLENE SUTURE 36"(90CM) 4-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10609611
• Report Number: 2210968-2020-07520
• Device Sequence Number: 16811879
• Product Code: GAW
• UDI-Device Identifier: 10705031022218
• UDI-Public: 10705031022218
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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): 09/23/2020

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: 8975H
• Device Catalogue Number: 8975H
• Device Lot Number: PCJ941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/16/2020
• Patient Sequence Number: 1