MAUDE Adverse Event Report: ETHICON, INC. VCL + CT BRD VIO 8X27IN USP3-0 S/A SH CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP784D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a hysterectomy procedure on (b)(6) 2026 and suture was used.During the procedure, it was reported that the needle broke when sewing in surgery.Changed another one to complete the surgery.There is no report on patient's injury.Enclosed please find defect photo.No additional information could be provided.No adverse patient consequences were reported.Additional information was requested.
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but unavailable: 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: ¿ what is the correct quantity of product involved (the available product photo shows two broken needles, but only one product involved was reported)? --since this code has 8 needles in one sterile package.Even though 2 of these 8 needles broke, they are from one package.¿ did the needle fall into the patient? if yes, was the needle piece removed from the patient during the same procedure? --no ¿ what was used to complete the procedure? --there are 8 needles in this package, and the needle broke after the procedure completed.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.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one empty foil packet and one winding former with six used needles were received for analysis.The product code vcp784 is multistrand and should contain eight strand per packet.During visual inspection of the needles, significant marks that appear to be caused by a surgical instrument were observed on the body needle.The tip and body of the needles were examined under magnification and no anomalies or issues related to needle breakage were found.In addition, one needle was tested by resistance test to needle and met the requirements.A photo was provided showing two broken needles.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.
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: the product received for analysis was vcp784d.Visual inspection and metallurgical analysis were performed on the returned product.One failed suture needle, labeled as (b)(4), were submitted to herrera, stafford and associates, llc (hsa) for fractographic evaluation on (b)(6) 2026.The components were identified as product code vcp784d.It was requested that hsa assess the fracture mode of the failures.A fracture was observed in the body of sample a and of sample b.The needles were 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 needles.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation of (b)(4) revealed the fractures were composed of microvoid coalescence, which is evidence of a ductile overload failure.These were ductile fractures.

• Brand Name: VCL + CT BRD VIO 8X27IN USP3-0 S/A SH CR
• 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: 24420914
• Report Number: 2210968-2026-01883
• Device Sequence Number: 5917585
• Product Code: GAM
• UDI-Device Identifier: 10705031055551
• UDI-Public: (01)10705031055551(17)300228(10)1070UG
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 03/27/2026

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: VCP784D
• Device Lot Number: 1070UG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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