MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ BI VIO 5IN2 USP4-0 D/A PS-4; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B101
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained: it was reported that "but it came out easily like pds and the barb did not get caught." please clarify, did this issue happened before or during surgery?=>maybe during surgery what do yo mean by "it came out easily like pds and the barb did not get caught" please elaborate:=>the barb did not get caught h6 component code: g07002 no device problem.H3 investigation summary the product was returned to ethicon for evaluation.One unused strand double armed outside its packaging was received for analysis.Product code sxpp2b101.During the visual inspection of the returned sample, the suture was examined along the strand and no anomalies were observed during evaluation.Ten barbs were measured in the strand, and all barbs met the 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 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 breast and endocrine surgery on (b)(6) 2025 and a barbed suture was used in a mammary gland case.During the procedure, it came out easily and the barb did not get caught.The suture that did not get caught was discarded.This event was found before use.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.

• Brand Name: SFX SPI PDS+ BI VIO 5IN2 USP4-0 D/A PS-4
• 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22903392
• Report Number: 2210968-2025-09846
• Device Sequence Number: 21065803
• Product Code: NEW
• UDI-Device Identifier: 10705031464698
• UDI-Public: (01)10705031464698(17)260430(10)1011TX
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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: 04/30/2026
• Device Catalogue Number: SXPP2B101
• Device Lot Number: 1011TX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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