MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 4-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP310H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.The following information was requested, but unavailable: was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, -is the patient part of a clinical study unknown, attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did the reported issue contribute to any patient adverse consequences? have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? a manufacturing record evaluation was performed for the finished device number, and no non-conformances were identified.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.The suture broke off from the needle for three patients.They opened a second suture because it broke off exactly by the needle whilst the doctor sutured the tissue together no adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 4-0 S/A SH-1
• 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: 24075273
• Report Number: 2210968-2026-00534
• Device Sequence Number: 18708787
• Product Code: GAM
• UDI-Device Identifier: 10705031052178
• UDI-Public: (01)10705031052178(17)280331(10)XDBBXTD0
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• 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): 01/14/2026

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: VCP310H
• Device Lot Number: XDBBXTD0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown