MAUDE Adverse Event Report: ETHICON INC. ETHILON BLACK 0.2M 30CM W/NDL; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1756

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What tissue was being approximated or sutured when the needle broke? was the needle piece removed from the patient during the same procedure? was there any patient consequence or injury? what is the condition of the patient? how was case completed? procedure name and date? event date? 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 an unknown date; and a suture was used.During the procedure,when the needle was clamped, the needle thread separated on one side of the double-ended needle, and the needle broke into two sections on the other side.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 09/15/2020.A manufacturing record evaluation was performed for the finished device batch: plh434, xcw1756 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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 BLACK 0.2M 30CM 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: 10263572
• MDR Text Key: 198548285
• Report Number: 2210968-2020-05232
• 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
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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 Catalogue Number: W1756
• Device Lot Number: PLH434
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 09/15/2020
• Patient Sequence Number: 1