MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 18"(45CM) 6-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	706G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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: procedure name? permanent coronary ligations.This suture was used to close skin incisions.What do you mean by suture is brittle? sutures breaks intra-op during use on mice.Did the suture break intra-op- during use on patient? yes.When was it noticed the "suture break with a slight force"? while doing surgeries on the very first animal of this cohort.Tried 3 different sutures and all had the same result.Pre-op- before use on patient or intra-op- during use on patient? intra-op- during use on patient while tying a knot to close skin incisions.
Event or Problem Description
It was reported that a mouse underwent a surgical procedure on an unknown date and suture was used.The suture was very brittle and prone to break with slight force.The suture broke during use.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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) 6-0 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: 8269095
• Report Number: 2210968-2019-78539
• Device Sequence Number: 2126270
• Product Code: GAP
• UDI-Device Identifier: 10705031008724
• UDI-Public: 10705031008724
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 04/30/2023
• Device Catalogue Number: 706G
• Device Lot Number: ME6911
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/20/2019
• Patient Sequence Number: 1