MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 2-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	C012D
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
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 the later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: it is reported "this event occurred in some needle-suture in a row¿.Please confirm the total qty involved? no information.Please confirm the needle didn't fall into patient? the needle(/s) did not fall into the patient.If it did, was it removed? and how? n/a.
Event or Problem Description
It was reported that the patient underwent a coronary artery bypass graft procedure on (b)(6) 2018 and the suture was used.During the procedure, the needle was detached from the suture when closing the chest.The needle did not fall into the patient.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: SILK SUTURE 18"(45CM) 2-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7636615
• Report Number: 2210968-2018-73779
• Device Sequence Number: 1719285
• Product Code: GAP
• UDI-Device Identifier: 10705031023390
• UDI-Public: 10705031023390
• Combination Product (Y/N): N
• PMA/510(K) Number: K946173
• 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): 05/31/2018

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 Expiration Date: 07/31/2022
• Device Catalogue Number: C012D
• Device Lot Number: LJQ133
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/02/2018
• Patient Sequence Number: 1