MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 2-0 S/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	X833H
Medical Device Problem Codes	Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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.Additional information was requested and the following was obtained: was there any adverse consequence associated with the patient? there were no adverse consequences associated with the patient.
Event or Problem Description
It was reported that a patient underwent a bariatric procedure on (b)(6) 2020 and suture was used.During the procedure, the needle easily popped off the suture at the swage.The suture would also easily fray.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 09/17/2020.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.H-3 summary: an opened box with thirty-two unopened samples of product were returned for analysis.The complaint sample was not received for evaluation.During the visual inspection of samples, no defects were found on the packages.The samples were opened, and swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, fraying or damaged were observed.A functional test was performed using an instron and the pull force were above the minimum requirements.Per the conditions of the samples received, no performance pull off suture needle or fraying suture was found, and the tested samples met the finished goods requirements.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 2-0 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: 10423686
• Report Number: 2210968-2020-06193
• Device Sequence Number: 2961201
• Product Code: GAT
• UDI-Device Identifier: 10705031058033
• UDI-Public: 10705031058033
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/10/2020

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: 10/31/2024
• Device Model Number: X833H
• Device Catalogue Number: X833H
• Device Lot Number: PMH788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1