MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ BI VIO 5IN2 0 DA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B409
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and barbed suture was used.It was reported by the sales rep that prior to an unknown procedure, there's another suture where one of the needles was off the stitch when they opened the package.Case completed with another device of the same product code.One device will be returned.Upon visual inspection of the detached needle, the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification, and no suture remnant was noted.In addition, the needle suture combination was visually inspected, and the swage area was noted to be as expected.The suture was examined and a short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement no adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).H3 investigation summary: the product was returned to ethicon for evaluation.One labeled winding former with a detached needle and one needle-suture combination that pertain to product code sxpp2b409.This product code is double armed.Upon visual inspection of the detached needle, the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification, and no suture remnant was noted.In addition, the needle suture combination was visually inspected, and the swage area was noted to be as expected.The suture was examined and a short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was detached from the needle since the insertion end of the suture did not meet the requirement.As the suture is absorbable and the duration of exposure of the suture in the environment could not be determined, the functional test could not be performed in the needle suture combination.A photo was provided showing one winding former with a detached needle and one needle suture.Based on the information currently available, short insertion issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: SFXSPI PDS+ BI VIO 5IN2 0 DA 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22338917
• Report Number: 2210968-2025-07489
• Device Sequence Number: 9060351
• Product Code: NEW
• UDI-Device Identifier: 10705031464674
• UDI-Public: (01)10705031464674(17)260131(10)UBBJQM
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 06/26/2025

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: 01/31/2026
• Device Catalogue Number: SXPP2B409
• Device Lot Number: UBBJQM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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