MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 9IN 2-0 SA CT-2; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B432
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a hysterectomy procedure on (b)(6) 2025 and barbed suture was used.During the procedure, it was reported by the sales rep that during a robotic hysterectomy, after vaginal cuff closure as they were pulling the suture out of the trocar.The needle snapped off the suture.Case was completed.No patient harm was reported.Device is available for return.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 needle suture piece in two sections and one empty foil were received for analysis.Product code sxpp1b432.The visual assessment of the returned sample noted that no needle pull-off.The needle was still attached to the suture piece.The ends of the suture pieces were noted to be cut and crushed probability cut by a surgical instrument.In addition, body fluids were noted on the sample.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.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following caution: as with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of surgical instruments, such as needle holders and forceps.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.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 via: lot number? 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.Provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).Lot number is on packaging sent back.Do not have it recorded.Physician is dr.(please refer the attached email).

• Brand Name: SFXSPI PDS+ UNI VIO 9IN 2-0 SA CT-2
• 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: 22056596
• Report Number: 2210968-2025-05623
• Device Sequence Number: 15247687
• Product Code: NEW
• UDI-Device Identifier: 10705031246539
• UDI-Public: (01)10705031246539(17)260131(10)UBBDEX
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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: SXPP1B432
• Device Lot Number: UBBDEX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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