MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 1 S/A CT; 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	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/26/2026 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: 1)did the needle fall into the patient? while handing over the suture to the surgeon, the needle tip was intact.When the suture was received back, the needle tip was noted to be missing.The surgeon was informed immediately.2)were x-rays taken to locate the needle piece(s)? yes.Multiple x-rays were taken intraoperatively to locate the needle tip; however, it could not be identified on imaging.3)what measures were implemented to retrieve the broken piece? as this was an open surgical wound, a thorough search was conducted, including inspection of the surgical wound, instruments, used swabs, and the operating room floor.Multiple x-rays were also performed.4)was there any additional tissue damage resulting from the search for the needle piece? no.There was no additional tissue damage.The incision was already large as required for the surgical procedure.5)does a fragment of the needle remain in the patient¿s tissue? it is uncertain.The needle tip could not be located on the patient¿s body via x-ray.6)is there any plan in place to remove the needle piece in the future? at present, the needle tip has not been located on patient body, and it is very small in size.In case of any future infection or surgical complications, the surgeon will assess and manage accordingly.7)in which tissue structure was the broken needle located? the surgery performed was a shoulder surgery.8)what is the surgeon¿s opinion regarding the potential consequences for the patient? as the needle tip was not visualized on x-ray, no specific concerns were identified at the time.If any related issues are noted in the future, they will be investigated and managed appropriately.9)source / title of external person providing answers to follow-up: the information was provided by the registered nurse who was scrubbed for the procedure on the day of surgery.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 an unknown procedure on an unknown date and suture was used.It was reported an incident of broken needle tip.There were no patient consequences reported.Additional information was requested.

• Brand Name: VCL+ VIO 36IN 1 S/A CT
• 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: 24180102
• Report Number: 2210968-2026-00962
• Device Sequence Number: 15956538
• Product Code: GAM
• UDI-Device Identifier: 10705031077881
• UDI-Public: (01)10705031077881(17)280229(10)XCBCQRW0
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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: VCP359H
• Device Lot Number: XCBCQRW0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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