MAUDE Adverse Event Report: ETHICON INC. ETHILON BLUE 2.0M 45CM W/NDL; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1625T

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: was surgery delayed due to the reported event? unknown, action taken when event occurred? switched to different ethicon suture code, was procedure successfully completed? yes, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences: unknown, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, what is the lot number? plh278 what is the event day and procedure date? orif left ankle, (b)(6) 2020.Please confirm device's availability.No, impacted product is not available.Code: w1625t.Any delay to surgery? no.Did this happen intra op: yes we were suturing skin.How was surgery completed? another suture opened and successfully sutured.Any patient outcomes: no remnants left behind.

Event Description

It was reported that a patient underwent an orif of the ankle on (b)(6) 2020 and suture was used.During the procedure, the needle came away from the suture during use.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 7/27/2020.A manufacturing record evaluation was performed for the finished device batch plh278, xaw1625t 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 45CM 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: 10147027
• MDR Text Key: 194939446
• Report Number: 2210968-2020-04548
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: W1625T
• Device Lot Number: PLH278
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Patient Sequence Number: 1