MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 4-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	X557H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported over the course of 2 cases the rb1 needle was popping off the suture and it's not a pop off suture.They wouldn't use anymore suture from that box.Got another box from another hospital with a different lot number to use for the next few weeks of cases.No adverse impact to the patient/user.Device is not available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/14/2025.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested; the following was obtained: please provide an answer for each patient-event: ¿ (b)(4) - case 1.¿ (b)(4) - case 2.- have any of these events been previously reported to ethicon? no if so, could you please provide the corresponding reference number(s)? - if this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? - when did the suture detached from the needle (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? during use - how many devices demonstrated the alleged deficiency? at least 3 instances.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Am (please refer to the attached email) vascular surgeon.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.

• Brand Name: EB EXC GRN 36IN 4-0 D/A RB-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23559970
• Report Number: 2210968-2025-12861
• Device Sequence Number: 10081701
• Product Code: GAT
• UDI-Device Identifier: 10705031057562
• UDI-Public: (01)10705031057562(17)281231(10)UAMKMK
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: X557H
• Device Lot Number: UAMKMK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2024
• 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