MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 0 S/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X834H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Events reported in medwatch reports 2210968-2020-06752.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 information was obtained: please provide lot number.Please provide procedure name and date.Status of product return / follow up.Complaint additional information - lot number mmh824.No product was saved so i will not be sending anything back.Procedure was svt ablation in the cath lab.
Event or Problem Description
It was reported that a patient underwent a svt ablation on (b)(6) 2020 and suture was used.During the procedure, when tension was put on the suture, it ripped in half.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/21/2020 additional information: d4, h4, h6 a manufacturing record evaluation was performed for the finished device batch mmh824, 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: EB EXC GRN 30IN 0 S/A SH
• 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: 10511777
• Report Number: 2210968-2020-06753
• Device Sequence Number: 3344354
• Product Code: GAT
• UDI-Device Identifier: 10705031058064
• UDI-Public: 10705031058064
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 10/31/2023
• Device Model Number: X834H
• Device Catalogue Number: X834H
• Device Lot Number: MMH824
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1