MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP603H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and a barbed suture was used.During surgery, the needle was broken at the swage part when closing the trocar wound during use.One needle was broken during use.It was not a control release needle.Another product was used to complete the case.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The following information was requested, but unavailable: - did the needle fall into the patient?=>unk.- was the needle piece(s) retrieved during the same procedure? - were x-rays taken to locate the needle piece(s)? - what measures were taken to retrieve the broken piece? - was there any additional tissue damage as a result of searching for the needle piece? - if not retrieved, in what tissue structure the needle was retained? is there any plan in place to remove the needle in the future? please provide details.- can you identify the lot number of the product involved? =>unk.H3 investigation summary: the product was returned to ethicon for evaluation.One dispensed needle suture piece and one empty labeled winding former that pertain to product code vcp603 were received for analysis.During the visual inspection of the returned sample, the swage and attachment area were noted to be as expected.The tip and body of the needle were examined under magnification and no anomalies or issues related to needle breakage were found.In addition, the samples were tested by resistance test to needle and met the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.H3 investigation summary: the product was returned to ethicon for evaluation.One needle that pertain to product code vcp603 was received.During visual inspection of the returned sample, it was observed that the needle was noted to be broken at the swage area.The other section of the needle was not returned for evaluation.This sample will be shipped to hsa for further analysis due to the needle breakage.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached due to the sample needs additional evaluation by hsa.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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 Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: h6, d9, h3.H3 investigation summary: a failed suture needle, labeled as (b)(4), was submitted to (b)(4) for fractographic evaluation on august 13, 2025.The component was identified as product code vcp603h.It was requested that hsa assess the fracture mode of the failure.According to the information, it was reported breakage needle.The product received for analysis was vcp603h visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed in the body of the needle.One side of the needle was received, the mating fracture surface was not provided 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 to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of predominantly microvoid coalescence, which is evidence of a ductile fracture mode.Transgranular fracture was also identified in small areas across the fracture surface.This was a ductile fracture.

• Brand Name: VCL+ VIO 27IN 0 S/A UR-6
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22773983
• Report Number: 2210968-2025-09231
• Device Sequence Number: 13124020
• Product Code: GAM
• UDI-Device Identifier: 10705031054394
• UDI-Public: 10705031054394
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: VCP603H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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