MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 3-0 D/A V-4; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X926H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been 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.Note: events reported in 2210968-2020-03828, 2210968-2020-03829 and add the report number for the new file.It was reported that the ¿needle pulling off suture issue occurred three time this week¿ when did the issue occur; in the package/ during dispensing (before use on patient/during actual suturing (use on patient)? procedure name initial procedure date the event occurred.Lot number device return status/follow up.To date, the device has not been returned.If the device or further details are received, a supplemental medwatch will be received.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle pulled of the suture.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/11/2020.Corrected h10 comment reported in the initial mw: note: events reported in 2210968-2020-03829, 2210968-2020-03834 and 2210968-2020-03837.

• Brand Name: EB EXC GRN 30IN 3-0 D/A V-4
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10044032
• Report Number: 2210968-2020-03834
• Device Sequence Number: 11729322
• Product Code: GAT
• UDI-Device Identifier: 10705031058330
• UDI-Public: 10705031058330
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: X926H
• Device Catalogue Number: X926H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 05/11/2020
• Patient Sequence Number: 1