MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	A304H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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.Additional information was requested and the following was obtained: can you clarify how many sutures broke? 6.Did they all break during this one procedure? yes.What is the lot number? lc6551.Was there any reported patient consequence and how was the case completed? no consequence to patient.Procedure was finished off with 3/0 silk, different batch number.
Event or Problem Description
It was reported that a patient underwent a varicose vein procedure on (b)(6) 2018 and suture was used.During the procedure, the suture broke.Another like device was used to complete the procedure with no adverse patient consequences.Additional information had been requested and was received.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.Unopened samples of product were returned for analysis.This product code requires twelve strands per packet.The unopened samples were examined and no defects were found on the packages.The samples were opened and sutures were examined along strand and no defects, damage or breakage suture were noted.A functional test was performed on the samples and the tensile force met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples received, no performance - breakage suture were found.

• Brand Name: SILK SUTURE 30"(75CM) 3-0 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: 7732990
• Report Number: 2210968-2018-74734
• Device Sequence Number: 1588349
• Product Code: GAP
• UDI-Device Identifier: 10705031023116
• UDI-Public: 10705031023116
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 07/05/2018

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: 02/28/2022
• Device Catalogue Number: A304H
• Device Lot Number: LC6551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 08/10/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 07/31/2018; 09/05/2018
• Patient Sequence Number: 1