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)
Type of Reportable Event	Malfunction
Additional 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.How many sutures that had "needles pop off" issue during this single procedure? please provide quantity of devices that were involved.How long was the delay? how was the retrieved from the patient? procedure date.A manufacturing record evaluation was performed for the finished device (b)(4) batch number, and no non-conformances were identified.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 or Problem Description
It was reported that a patient underwent a cardiovascular procedure on an unknown date; and a suture was used.During the procedure, the suture pulled off the needle while sewing in the aortic cannula.There were no adverse patient consequences reported.Additional information was requested.

• 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: 10096285
• Report Number: 2210968-2020-04219
• Device Sequence Number: 3156412
• Product Code: GAT
• UDI-Device Identifier: 10705031058330
• UDI-Public: 10705031058330
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 05/19/2020

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 Expiration Date: 11/30/2024
• Device Model Number: X926H
• Device Catalogue Number: X926H
• Device Lot Number: PPMHRC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 05/28/2020
• Patient Sequence Number: 1