MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 2-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP417H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.It was reported that during the mesh implantation portion of surgery the tip of the needle sheared off; unable to retrieve.Retained needle tip in fascia and mesh was reapplied.No harm to patient; patient informed.Device is not available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 2/12/2026.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 the needle piece(s) retrieved during the same procedure? it was unable to be retrieved as stated in the original report.Were x-rays taken to locate the needle piece(s)? yes, xray performed.Confirmed to be above the facial closure.What measures were implemented to retrieve the broken piece? the incision was expanded; mesh was removed and was unable to be located; xray taken and confirmed above the facial closure in the soft tissue.Determined risk was greater to continue search and the sub-cm tip was retained.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? as stated in the original report, yes, the needle fragment is retained in the tissue.If so, is there any plan in place to remove the needle piece in the future? at this point, no plan to remove.If so, could you please provide the scheduled date for the removal? n/a in which tissue structure was the broken needle located? confirmed by xray to be above the facial closure in the soft tissue.What is the surgeon¿s opinion of the potential consequences for the patient? it was decided that this posed little to no risk to the patient and the further dissection would only lead to the possibility of losing the fragment into the abdominal cavity so the decision was made to leave it in place.The patient was informed and remains asymptomatic from office visit on (b)(6) 2025- no further intervention per general surgeon.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.User facility medwatch form mw5181055.

• Brand Name: VCL+ UD 27IN 2-0 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: 24327425
• Report Number: 2210968-2026-01597
• Device Sequence Number: 9476060
• Product Code: GAM
• UDI-Device Identifier: 10705031053038
• UDI-Public: (01)10705031053038(17)300430(10)108EHC
• 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: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: VCP417H
• Device Lot Number: 108EHC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2025
• 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