MAUDE Adverse Event Report: ETHICON INC. ETHILON* UND 4-0 45CM (1)E-19; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 1111T

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

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.

Event Description

It was reported that a patient underwent a surgical procedure to drain an abscess on (b)(6) 2018 and suture was used.During the procedure, the needle pulled of from the suture.There were no adverse patient consequences reported."did the patient have permanent damage?" no."did the patient need hospitalization or had hospitalization prolonged due to a product problem?" no."did the patient need to be reoperated to avoid or correct any damage?" no."did the patient have any serious damage?" no."did any part fall into the patient?" no.

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Device evaluation summary: the actual device was received for evaluation.A loose needle and a broken suture of product code 1111t, lot# aj9608 were returned for analysis.The loose needle was examined for visual inspection under magnification, the swage and attachment area were as expected.The suture was inspected along the strand, the end of the suture cut (broken) was noted.In addition, several pinch marks near to the thread broken, that appears to be by a surgical instrument could be observed.According to the samples condition, the assignable cause of suture needle pull off is due to improper handling of the sample.When handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7661644
• MDR Text Key: 113315838
• Report Number: 2210968-2018-74074
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 1111T
• Device Lot Number: AJ9608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1