MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+BI VIO 14IN2 USP2-0 D/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B412
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
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.H.6.Component code: g07002 device not returned.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: could you please clarify if the extra devices belong to this complaint? the extra devices are a part of the same complaint.Both were lot numbers were involved in the customer complaint.If not, could you please clarify if the extra devices received belong to a different complaint? if so, can you please provide the complaint number.N/a.If the devices were not reported before, please provide more details of the device malfunction.Needle popped off during suturing.If the products don¿t belong to any complaint, please let us know so we can discard them or advise if the product is required to be returned.N/a.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.N/a.The extra devices are a part of the same complaint.Both were lot numbers were involved in the customer complaint.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and barbed suture was used.During the procedure, the needle kept popping off when they were running the stitch.No patient harm reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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 was returned to ethicon for evaluation.Ten unopened samples were received for analysis.The product code sxpp2b412 is double armed.To evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during evaluation.Additionally, each sample was evaluated by measuring the barbs per suture and met whit the specification.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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, and no non-conformances were identified.

• Brand Name: SFX SPI PDS+BI VIO 14IN2 USP2-0 D/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23096539
• Report Number: 2210968-2025-10741
• Device Sequence Number: 15828548
• Product Code: NEW
• UDI-Device Identifier: 10705031464520
• UDI-Public: (01)10705031464520(17)260630(10)10278Q
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K192144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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 Expiration Date: 06/30/2026
• Device Catalogue Number: SXPP2B412
• Device Lot Number: 1021BD
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 09/28/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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