MAUDE Adverse Event Report: ETHICON INC. ETHILON BLUE 2.0M 75CM W/NDL; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1685T

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 arthroscopy on (b)(6) 2020 and suture was used.During the procedure, the thread came away from needle on use.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch pgp729, xcw1685t and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ETHILON BLUE 2.0M 75CM W/NDL
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10133646
• MDR Text Key: 194507577
• Report Number: 2210968-2020-04437
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

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: 05/31/2024
• Device Catalogue Number: W1685T
• Device Lot Number: PGP729
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 07/29/2020
• Patient Sequence Number: 1