MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8318H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 04/28/2021.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.Additional information was requested and the following information was obtained: it was reported that ""during an unknown cardiovascular surgery, suture breakage occurred frequently during use." could you please specify the quantity of devices that presented suture breakage during this single procedure (cardiovascular procedure) being reported? =>the sales rep reported that the qty of product involved is 1.What was used to complete the procedure? no further information is available.Device return status/follow up we regularly contact with sales rep about the device returning.No further information will be provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a cardiac procedure on (b)(6) 2021 and suture was used.During the procedure, the suture broke.Another like device was used to complete the procedure.There were no adverse events or patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/25/2021.Additional information: 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.Additional information was requested, and the following was obtained: we got this info from the sales-rep on 30_april_2021.Quantity to be returned: 1 => 0 date sent to the fda: 5/25/2021.A manufacturing record evaluation could not be completed as the lot number provided is invalid.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 18"(45CM) 6-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11742558
• Report Number: 2210968-2021-03980
• Device Sequence Number: 4357419
• Product Code: GAW
• UDI-Device Identifier: 10705031014305
• UDI-Public: 10705031014305
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 8318H
• Device Catalogue Number: 8318H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1