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) h6 component code: g07002 - no device problem found.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.H3 investigation summary: the product was returned to ethicon for evaluation.Thirty-eight unopened samples were received for analysis.The product code sxpp2b412 is double armed.As per the sampling plan, a visual inspection was performed on thirteen 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.
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, it was reported by the sales rep that during an unknown procedure, the needle keep popping off when they were running the stitch.No patient harm reported.Devices are available for return.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/10/2025 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 device has been received, however clarification is requested whether the product belongs to this complaint.The following information was requested: product code: (10) sxpp2b412 product batch: 1021bd 1.Could you please clarify if the extra devices belong to this complaint? 2.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.3.If the devices were not reported before, please provide more details of the device malfunction.4.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.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to productcomplaint1@its.Jnj.Com with the ups, dhl or fedex tracker number.6.Please provide the source or name of the person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).
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 d4 udi number.Additional information: g4.Additional information was requested, and the following was obtained: 1.Could you please clarify if the extra devices belong to this complaint? 2.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.3.If the devices were not reported before, please provide more details of the device malfunction.4.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.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.1.The extra devices are a part of the same complaint.¿ both were lot numbers were involved in the customer complaint.2.N/a.3.Needle popped off during suturing.4.N/a.5.N/a.

• 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: 22782365
• Report Number: 2210968-2025-09256
• Device Sequence Number: 13273154
• Product Code: NEW
• UDI-Device Identifier: 10705031464520
• UDI-Public: (01)10705031464520(17)260630(10)10278Q
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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: 10278Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2025
• 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: 08/12/2025; 09/15/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/10/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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