MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 18"(45CM) 4-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y464G

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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: did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? no.

Event Description

It was reported that an animal underwent a dental procedure on (b)(6) 2018 and suture was used.During the procedure, the needle detached upon one passage through the tissue.Another like device was used to complete the procedure with no adverse patient consequences.No additional information is available.

Manufacturer Narrative

Pc-(b)(4).An empty opened box, an empty labeled winding former, a dispensed suture and a detached needle were returned for analysis.During the visual inspection of detached needle, the swage and attachment area were as expected.The barrel hole was examined under magnification and remnant suture was noted.The suture end is severely cut (damaged), resulting in a clip off defect.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.

• Brand Name: MONOCRYL SUTURE 18"(45CM) 4-0 VIO
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7312835
• MDR Text Key: 101656937
• Report Number: 2210968-2018-71263
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059269
• UDI-Public: 10705031059269
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: Y464G
• Device Lot Number: LL6571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1