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

Catalog Number	VCP329H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
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.Corrected information: d4 udi.Additional information: d9, h3, h6.Additional h3 investigation summary: a failed suture needle was for fractographic evaluation.The component was identified as product code vcp329h.It was requested to assess the fracture mode of the failure.According to the information, it was reported breakage needle.The product received for analysis was vcp329h visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage and a cup-and-cone shaped fracture provide additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.Attempts have been made to retrieve the device.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: were the needle pieces retrieved during the same procedure? yes - were x-rays taken to locate the needle pieces? no - what measures were implemented to retrieve the broken pieces? n/a - was there any additional tissue damage resulting from the search for the needle pieces? n/a - does a fragment of the needle remain in the patient¿s tissue? no if so, is there any plan in place to remove the needle piece in the future? n/a ¿ if so, could you please provide the scheduled date for the removal? ¿ in which tissue structure was the broken needle located? n/a ¿ what is the surgeon's opinion of the potential consequences for the patient? no negative effects to the patient - could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided product has been returned fedex tracking # (b)(4).- please provide the source or name of person providing answers to follow-up questions: nurse manager: (please refer the attached email).
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2025 and suture was used.During the procedure, it was reported to the sales rep that, two suturing needles broke while passing through the patient's skin.Patient's adverse event was not determined.Product is available for return.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 0 S/A CT-3
• 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: 22808591
• Report Number: 2210968-2025-09348
• Device Sequence Number: 12973421
• Product Code: GAM
• UDI-Device Identifier: 10705031052352
• UDI-Public: (01)10705031052352(17)291031(10)104JE4
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: VCP329H
• Device Lot Number: 104JE4
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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