MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 2-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8977H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/10/2020.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 name of the initial procedure? inguinal hernia.What was used to complete the procedure? same like product.Was the surgery completed successfully? yes.Was the surgery delayed due to the issue? no.How many of the total quantity were actually involved in the reported issue? 3 sutures.Note: events reported via mw 2210968-2020-02919, 2210968-2020-02920, 2210968-2020-02921.
Event or Problem Description
It was reported that the patient underwent an inguinal hernia procedure on an unknown date and suture was used.The suture split during use.The procedure was successfully completed with a like device.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 07/20/2020.A manufacturing record evaluation was performed for the finished device batch pjp837,and no non-conformances were identified.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 36"(90CM) 2-0 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: 9949953
• Report Number: 2210968-2020-02920
• Device Sequence Number: 3436004
• Product Code: GAW
• UDI-Device Identifier: 10705031022256
• UDI-Public: 10705031022256
• 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): 03/17/2020

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: 07/31/2024
• Device Model Number: 8977H
• Device Catalogue Number: 8977H
• Device Lot Number: PJP837
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 07/20/2020
• Patient Sequence Number: 1