MAUDE Adverse Event Report: ETHICON INC. MONOCRYL VIO 27IN USP3-0::S/A SH-1 PLUS VB; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y3110H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

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.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and suture was used.During the procedure, the needle pulled off from the thread during the closing of first knot.The needle was retrieved.There were no adverse patient consequences reported.No additional information has been provided.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.It was reported performance pull off suture needle.A detached needle was received for evaluation.During the visual inspection of a needle, the swage and attachment area were as to be expected.The hole of the needle was examined under 20x magnification for suture remnant and remnant was found into to hole and marks on body and edge needle that appears to be by use of the surgical instruments.This condition caused the performance - pull off suture needle.The suture was not returned for evaluation to avoid this kind of damage the packages, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Per the needle condition the assignable cause of the performance - pull off suture needle, was an improper handling.

• Brand Name: MONOCRYL VIO 27IN USP3-0::S/A SH-1 PLUS VB
• 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.-UK; simpson parkway; kirkton campus; livingston ; UK
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7518631
• MDR Text Key: 108417373
• Report Number: 2210968-2018-72830
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/23/2018

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: 08/31/2022
• Device Catalogue Number: Y3110H
• Device Lot Number: LC7CMLN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 09/19/2018
• Supplement Dates FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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