MAUDE Adverse Event Report: ETHICON INC. PROLENE SUT 30IN(75CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8776H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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.Additional information was requested and the following was obtained: what is the procedure date? (b)(6) 2020 what is the patient's condition? there is no pat.Damage just a not significant surgery time extension.Device return status/follow up the product has been sent to our location.Note: events reported via mw 2210968-2020-04531, 2210968-2020-04532.
Event or Problem Description
It was reported that the patient underwent aorto bi-prosthesis procedure on (b)(6) 2020 and suture was used.The suture was broken when needle penetrated tissue.The surgeon needed two sutures to finish the anastomosis.There were no patient consequences reported, just a not significant surgery time extension.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 09/30/2020.A manufacturing record evaluation was performed for the finished device batch plj550, and no non-conformances were identified attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Why were samples from product code 8975, lot pgr645 returned under this file? is there a complaint against product code 8975, lot pgr645? is any product being returned for product code 8776h, lot plj550, which this complaint is about? 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 SUT 30IN(75CM) 6-0 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: 10145463
• Report Number: 2210968-2020-04532
• Device Sequence Number: 3851958
• Product Code: GAW
• UDI-Device Identifier: 10705031020481
• UDI-Public: 10705031020481
• Combination Product (Y/N): N
• 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): 06/04/2020

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: 8776H
• Device Catalogue Number: 8776H
• Device Lot Number: PLJ550
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 09/30/2020
• Patient Sequence Number: 1