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)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.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.Please confirm that 1 suture broke during this one procedure?.
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass graft on (b)(6) 2019 and suture was used.During the procedure, the suture was broken during use.This event occurred in some needle-sutures.There were no adverse consequences to the patient.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).The following additional information was obtained: the total number of suture breakage is unknown.No further information will be provided.

• 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: 8603719
• Report Number: 2210968-2019-81302
• Device Sequence Number: 1857495
• 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): 04/16/2019

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: 04/16/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/11/2019
• Patient Sequence Number: 1