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

Catalog Number	J316H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/30/2026.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.Additional information was requested, the following was obtained: did the needle fall into the patient? no.If so, was the needle piece(s) retrieved during the same procedure? yes, only for one needle.Were x-rays taken to locate the needle piece(s)? yes, in operating room.What measures were implemented to retrieve the broken piece? x- rays.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, from what can be seen from the x-ray results.If so, is there any plan in place to remove the needle piece in the future? no.If so, could you please provide the scheduled date for the removal? no.In which tissue structure was the broken needle located? no, the needle tip was found on the surgical forceps.What is the surgeon¿s opinion of the potential consequences for the patient? in the post-operative period, the patient had cellulitis in the axillary cavity treated with antibiotic therapy and a seroma in the quadrant, not necessarily attributable to the event, as they are very frequent.Could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.Product available and will be shipped to jnj in the upcoming days.Please provide the source or name of person providing answers to follow-up questions: (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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent a quadrantectomy and axillary sentinel lymph node procedure for breast cancer on (b)(6) 2026 and suture was used.During the quadrantectomy and axillary sentinel lymph node procedure for breast cancer: the closure of the quadrantectomy was performed.At the time of suturing the axillary wound, it was noticed that the suture needle was missing its free tip.The fragment was immediately found on the forceps in use at that moment and measured about 4 mm.During the final count of needles used throughout the procedure, it was noted that a second needle had the same issue: missing tip.The patient then underwent an intraoperative x-ray which did not show the presence of any foreign body.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/22/2026.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.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• 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: 24727573
• Report Number: 2210968-2026-03251
• Device Sequence Number: 18452183
• Product Code: GAM
• UDI-Device Identifier: 10705031038738
• UDI-Public: (01)10705031038738(17)310228(10)XKBCJBH0
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K022269
• 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,Followup,Followup
• Report Date (Section B): 05/08/2026

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 Catalogue Number: J316H
• Device Lot Number: XKBCJBH0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 04/28/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/22/2026; 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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