MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 1 S/A CT-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X425H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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 was used to complete the procedure? did the needle pull off during the procedure? did the needle fall into the patient? were x-rays taken? please provide the status of the device(s) as it has not been received for analysis.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the suture popped off while the surgeon was closing fascia.It is unknown how the case was completed.There were no patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot php736, and no non-conformances were identified.

• Brand Name: EB EXC GRN 30IN 1 S/A CT-1
• 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: 9641164
• Report Number: 2210968-2020-00763
• Device Sequence Number: 1965443
• Product Code: GAT
• UDI-Device Identifier: 10705031057296
• UDI-Public: 10705031057296
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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: 06/30/2024
• Device Model Number: X425H
• Device Catalogue Number: X425H
• Device Lot Number: PHP736
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/10/2020
• Patient Sequence Number: 1