MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 8-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	M8730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a coronary artery bypass graft procedure on an unknown date in 2019 and suture was used.The suture broke during use.No additional information was provided.There were no patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch mjj818 and no non-conformances were identified.

• Brand Name: PROLENE SUTURE 18"(45CM) 8-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8691375
• Report Number: 2210968-2019-82652
• Device Sequence Number: 19297286
• Product Code: GAW
• UDI-Device Identifier: 10705031045941
• UDI-Public: 10705031045941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/16/2019

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: 07/31/2023
• Device Catalogue Number: M8730
• Device Lot Number: MJJ818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 06/14/2019
• Patient Sequence Number: 1