MAUDE Adverse Event Report: ETHICON INC. COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP359H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/24/2026.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: were there any unexpected outcomes or complications resulting from the prolonged surgery time? no.How long, in minutes, did the surgery prolong? 10/50 min.Which tissue was being sutured when the event occurred? uterus.Was additional dissection required in other organs/tissues other than the target tissue? no.Was there any change in the patient¿s post-operative care due to the prolonged procedure? no.Was the needle piece(s) retrieved during the same procedure? yes.Were x-rays taken to locate the needle piece(s)? no.What measures were taken to retrieve the broken piece? scrupulous abdominal research.Was there any additional tissue damage as a result of searching for the needle piece? no.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) (b)(6).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.
Event or Problem Description
It was reported that a patient underwent a caesarean section on (b)(6) 2026 and suture was used.As part of a caesarean section, during the closure phase during the suture of the abdominal fascia, the tip of the needle of our suture broke.The tip was then, after a careful search, found and removed from the patient.The suture thread in question (with attached needle) and the entire package of the same batch were sent to the hospital pharmacy to open a report to the ministry.A significant delay was reported.There were no patient consequences reported.Additional information was requested.

• 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.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24675079
• Report Number: 2210968-2026-03006
• Device Sequence Number: 16003472
• Product Code: GAM
• UDI-Device Identifier: 10705031077881
• UDI-Public: (01)10705031077881(17)260531(10)TGBBDJW0
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K132580
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 05/31/2026
• Device Catalogue Number: VCP359H
• Device Lot Number: TGBBDJW0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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