MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 6-0 BLU; SUTURES - NON-ABSORBABLE

Model Number	EP8776H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested, and the following was obtained: what is the procedure date? (b)(6) 2020 aortobiiliacaler bypass what is the event date? (b)(6) 2020 inoperative 3rd sutures had to be used until suturing was successful.What is the patient's current condition? no information that the patient isn't well events were submitted via 2210968-2020-04539, 2210968-2020-04540 and 2210968-2020-04541.
Event or Problem Description
It was reported that the patient underwent an aortobiiliacal bypass procedure on (b)(6) 2020 and the suture was used.The suture broke when needle was inserted or when suture was knotted.Another like suture was used to complete the procedure successfully.
Additional Manufacturer Narrative
Date sent to the fda: 08/07/2020.A manufacturing record evaluation was performed for the finished device batch plj550 and no non-conformances were identified.Additional h-3 summary: one sealed box with thirty-six unopened samples, one open box with thirty-five unopened samples and two unopened samples of product code 8776, lot plj550 were received for analysis.During the visual inspection, 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 observed.A functional test was performed and the tensile strength force was above the minimum requirement.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.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 inc, 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 30"(75CM) 6-0 BLU
• Common Device Name: SUTURES - NON-ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10146770
• Report Number: 2210968-2020-04541
• Device Sequence Number: 2177206
• Product Code: GAW
• UDI-Device Identifier: 10705031231238
• UDI-Public: 10705031231238
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/02/2020

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: 09/30/2024
• Device Model Number: EP8776H
• Device Catalogue Number: EP8776H
• Device Lot Number: PLJ550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1