MAUDE Adverse Event Report: ETHICON, INC. VCL+ UD 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP416H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).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.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: please confirm whether the needle or suture broke.The needle were any needle fragments retrieved during the same procedure? if not, describe the efforts made to locate and retrieve them.The needle body broke in half.One part of it was still attached to the needle driver and the second half was embedded in the skin which was removed safely, easily and without any issues or complications.Were x rays performed to locate the needle fragments? if so, please summarize the findings.None required since the needle broke in half and both pieces were visible to the surgeon and removed safely from the patient and field.Is this device or samples from same lot available for analysis? if yes, to whom should the shipper kit be sent? (please provide contact name, department, street address including zip, no po box please, email address, and phone number).Yes.We have unopened boxes that can be sent for analysis.Address, email, phone.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).The manufacturing records could not be reviewed as the batch/lot number is unknown.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.During the procedure, 3-0 vicryl suture broke in half during use, in soft tissue.Piece was embedded in [redacted] until located by surgeon and removed.Lot: 1099 ep, ref: vcp416, exp: 05/31/2030.Vcl+ ud 27in 3-0 s/a sh - vcp416h (lot: 1099ep) (vcp416h): right side.Vcl+ ud 27in 3-0 s/a sh - vcp416h (lot: 1099ep) (vcp416h): lot/batch number: 1099ep.List any j&j products that were utilized during the case but did not contribute to the reported event.Was there any reported patient or user harm? no.Was there a significant delay? no.If available, provide the product order number (po).Do you need product packaging to send the product back? no.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/20/2026.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.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: VCL+ UD 27IN 3-0 S/A SH
• 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 ; 3035526892
• MDR Report Key: 24153286
• Report Number: 2210968-2026-00856
• Device Sequence Number: 13276558
• Product Code: GAM
• UDI-Device Identifier: 10705031053014
• UDI-Public: (01)10705031053014(17)300531(10)1099EP
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• 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,Followup
• Report Date (Section B): 01/22/2026

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: VCP416H
• Device Lot Number: 1099EP
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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