MAUDE Adverse Event Report: Ethicon Inc. Coated VICRYL; Suture, Absorbable, Synthetic

Catalog Number	VCP346H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a robotic bso procedure on (b)(6)2026 and suture was used.During a robotic (bso) procedure, the physician was using an o vicryl suture when the needle snapped in half.All portions of the broken needle were successfully retrieved.The physician also stated that this issue has occurred multiple times with the same suture while using minimal pressure.No patient consequences were reported.Device return status was not provided.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 8/27/2026.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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: how many devices demonstrated the alleged deficiency? one defective device in this procedure.Did the event occur during one or multiple patient procedures? 1.What is the total number of procedures? 1.Have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? only reported case, but doctor specified that this has multiple times with the exact same suture code in recent surgeries.During entry with (b)(6), needle snapped in half.If this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? did the needle fall into the patient? unknown.Were x-rays taken to locate the needle piece(s)? no.What measures were implemented to retrieve the broken piece? needle broke and was retrieved visually.Was there any additional tissue damage resulting from the search for the needle piece? no.Does a fragment of the needle remain in the patient¿s tissue? no.If yes, was more than half the needle retained in the patient? is there any plan in place to remove the needle piece in the future? if yes, could you please provide the scheduled date for the removal? in which tissue structure was the broken needle located? unknown.What is the surgeon's opinion of the potential consequences for the patient? no consequence to the patient.Please provide the source or title of external person providing answers to follow-up: (b)(6) (please refer to the attached email) materials manager.Please reply directly to this email.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: Coated VICRYL
• Common Device Name: Suture, Absorbable, Synthetic
• 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 ; +1(303)552-6892
• MDR Report Key: 50483371
• Report Number: 2210968-2026-08738
• Device Sequence Number: 10338866
• Product Code: GAM
• UDI-Device Identifier: 10705031077812
• UDI-Public: (01)10705031077812(17)310228(10)10EAP7
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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: VCP346H
• Device Lot Number: 10EAP7
• 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: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2026
• 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