MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 9IN 0 SA V-34; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B457
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
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.Three unused open samples outside the foil packets were received for analysis.Product code sxpp1b457.During the visual inspection of the returned samples, the swage and attachment area were noted to be as expected.The suture were 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 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.H3 investigation summary: the product was returned to ethicon for evaluation.Eighteen unopened samples were received for analysis.Product code sxpp1b457.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and 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 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.- when did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? during passage through tissue and upon inspection prior to use of a 2nd suture from the same lot.- please provide lot number.Lot# 106kc3 - please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.I shipped these via fedex today (5/23/25) tracking # (b)(4).Additional information was requested, and the following was obtained via: - provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Dr (b)(4).
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2025 and barbed suture was used.During the procedure, it was reported by the sales rep that the surgeon noticed that the barbs on the suture were not there like they're supposed to be.He was concerned that it would hold.He used a different suture for closure.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SFXSPI PDS+ UNI VIO 9IN 0 SA V-34
• 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: 22197673
• Report Number: 2210968-2025-06738
• Device Sequence Number: 9227634
• Product Code: NEW
• UDI-Device Identifier: 10705031240896
• UDI-Public: (01)10705031240896(17)270131(10)106KC3
• 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): 06/12/2025

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 Catalogue Number: SXPP1B457
• Device Lot Number: 106KC3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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