MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 12IN 3-0 SA PS-2 PR; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B104
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
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.H3 investigation summary: the product was returned to ethicon for evaluation.One used needle suture combination outside the winding former was received for analysis.Product code sxpp1b104.During visual inspection of the sample, the swage and attachment area were noted to be as expected.Marks on the body needle appear to be by use of surgical instrument could be observed.The suture was examined, body fluids were found.In addition, it was observed that the weld of first loop was detached.However, the loop possibly failure due to excessive force applied.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.No conclusion could be reached as on what caused the reported complaint.The instructions for use do contain the following caution: for the device to function properly, the stratafix¿ spiral pds¿ plus device must first be anchored in robust tissue using the fixation loop.Then subsequently engage the barbs into the tissue in a standard closure pattern.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.
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 a sales rep that, during an unknown surgery, it was found that the loop had been untied before use.Another product was used to complete the case.During visual inspection of the sample, the swage and attachment area were noted to be as expected.Marks on the body needle appear to be by use of surgical instrument could be observed.The suture was examined, body fluids were found.In addition, it was observed that the weld of first loop was detached.There were no adverse reported.Additional information was requested.

• Brand Name: SFXSPI PDS+ UNI VIO 12IN 3-0 SA PS-2 PR
• 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: 21901654
• Report Number: 2210968-2025-04479
• Device Sequence Number: 11817590
• Product Code: NEW
• UDI-Device Identifier: 10705031236240
• UDI-Public: (01)10705031236240(17)260430(10)1011GA
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K150670
• 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
• Report Date (Section B): 04/24/2025

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: SXPP1B104
• Device Lot Number: 1011GA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/24/2025
• 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