MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 3-0 D/A SH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	X522H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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 via: * did the needle fall inside the patient?=>unk no pieces were left inside the patient.If yes, how was it retrieved? * can you identify the lot number of the products used?=>unk please provide additional details (number of products per lot that had this issue).=>5, but the lot is unknown.* what is the procedure name? =>unk * please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep)(b)(6) * please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.Ions.=>we regularly contact with sale rep about the device returning.The manufacturing records could not be reviewed as the batch/lot number is unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an aortic dissection procedure on (b)(6) 2025 and suture was used.During the procedure, it was reported by a sales rep that, the suture breakage occurred during use.Even after changing the lot, the suture breakage continued to occur.On the way, the needle was lost sight sometimes due to the suture was broken, and this was led to extend the operation time.It was not a control release needle.Additional suture was performed to complete the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d 3.Manufacturer email.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, or its employees that the report constitutes an admission that the product, ethicon, 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 36IN 3-0 D/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21447632
• Report Number: 2210968-2025-02024
• Device Sequence Number: 15243436
• Product Code: GAT
• UDI-Device Identifier: 10705031057432
• UDI-Public: 10705031057432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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 Catalogue Number: X522H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown