MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 2 X 24"(60CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8747
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
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 a patient underwent a coronary artery bypass graft on (b)(6) 2020 and suture was used.During coronary anastomosis, the suture was broken.The surgeon commented that the suture was caught on the blue covering cloth, causing the suture breakage.The needle had not fallen into the patient.The needle could be found immediately.The operation time was extended within 30 minutes.There were no adverse consequences to the patient.No additional information was provided.

• Brand Name: PROLENE SUTURE 2 X 24"(60CM) 7-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9780827
• Report Number: 2210968-2020-01696
• Device Sequence Number: 2649796
• Product Code: GAW
• UDI-Device Identifier: 10705031203693
• UDI-Public: 10705031203693
• 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
• Report Date (Section B): 02/05/2020

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 Model Number: EPM8747
• Device Catalogue Number: EPM8747
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1