MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 3-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8926H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).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 asc aorta replacement and avr procedure on (b)(6) 2019 and suture was used.The suture broke while tying suture on the aorta.Case completed with suture of an unknown product code.There were no patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device batch number mhr621 and no non-conformances were identified.

• Brand Name: PROLENE SUTURE 36"(90CM) 3-0 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: 9200562
• Report Number: 2210968-2019-88760
• Device Sequence Number: 14229976
• Product Code: GAW
• UDI-Device Identifier: 10705031022010
• UDI-Public: 10705031022010
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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: 06/30/2023
• Device Catalogue Number: 8926H
• Device Lot Number: MHR621
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/13/2019
• Patient Sequence Number: 1