MAUDE Adverse Event Report: ETHICON INC. VCL + BRD UD 8X18IN USP4-0 S/A RB-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP714D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a gastrointestinal anastomosis procedure on (b)(6) 2025 and suture was used.No needle tip.It was reported that there had been no needle tip on the needle of one of the sutures in the newly dispensed suture when it was opened to prepare for surgery.Changed another one to complete the surgery.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.H6 type of investigation: c22 ¿ photo investigation.H3 investigation summary the product was returned to ethicon for evaluation.One winding former with five used needle suture pieces and two detached needles were received for analysis.The product code vcp714d is multistrand and should contain eight strands per packet.During the visual inspection of the needles, the swage and attachment area were noted as expected.The tip and body of the needles 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.Two photos were provided, one photo showed two needle suture, while in the other a foil packet was observed.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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 complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device 103x5k / vcp714d35 batch 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.
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 herrera, stafford and associates, llc (hsa) for fractographic evaluation on july 8, 2025.The component was identified as product code vcp714d.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 vcp714d.Visual inspection and metallurgical analysis were performed on the returned product.A blunt tip was observed.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 a blunt tip.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL + BRD UD 8X18IN USP4-0 S/A RB-1 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: 22520472
• Report Number: 2210968-2025-08200
• Device Sequence Number: 20970161
• Product Code: GAM
• UDI-Device Identifier: 10705031055018
• UDI-Public: (01)10705031055018(17)290930(10)103X5K
• 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): 08/04/2025

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: VCP714D
• Device Lot Number: 103X5K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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