MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 4-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y935H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2018
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.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.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how?.
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass graft procedure on (b)(6) 2018 and suture was used.During the procedure, after passing thru the subcuticular tissue, the suture popped off at the swage.Another like device was used to complete the procedure with no adverse patient consequences.Additional information has been requested.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 4-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7312788
• Report Number: 2210968-2018-71261
• Device Sequence Number: 19246499
• Product Code: GAN
• UDI-Device Identifier: 10705031059894
• UDI-Public: 10705031059894
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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 Catalogue Number: Y935H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1