MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ UNI VIO 6IN 2-0 SA SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B415
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
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 a laparoscopic hysterectomy, the needle tip exhibited bending during tissue penetration.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 photo investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a needle with a broken tip being held by the user.Because of the needle's position, it is not possible to determine whether the needle has lost its original curvature.Based on the photo review, the event reported is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon 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.The following information was requested, but unavailable: attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional h11: was surgery delayed due to the reported event? --> yes, if yes, number of minutes: --> 5, action taken when event occurred? --> open other suture, was procedure successfully completed? --> yes, were fragments generated? --> no, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, (b)(4).Device property of -->none, device in possession of -->none.Additional information was requested, and the following was obtained via: it was reported that the needle tip bent during tissue penetration; however, the attached photograph appears to show a broken needle tip.Could you please provide further details about the issue reported with the product? the needle was completely bent, almost at a 90-degree angle.When they decided not to use it anymore, the scrub nurse took it, bent it slightly, and it broke.Were there any unexpected outcomes or complications resulting from the prolonged surgery time? yes, since it was stratafix, the reverse closure could not be performed, so another suture had to be opened.Which tissue was being sutured when the event occurred? vaginal cuff.Was additional dissection required in other organs/tissues other than the target tissue? no.Was there any change in the patient¿s postoperative care due to the prolonged procedure? no.Please provide the source or name of person providing answers to follow-up questions: (please refer to the attached mail) please provide the source or title of external person providing answers to follow-up: no.

• Brand Name: SFXSPI PDS+ UNI VIO 6IN 2-0 SA SH
• 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: 23837125
• Report Number: 2210968-2025-14200
• Device Sequence Number: 12035439
• Product Code: NEW
• UDI-Device Identifier: 10705031235885
• UDI-Public: (01)10705031235885(17)260531(10)101C9B
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• 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): 12/18/2025

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: 05/31/2026
• Device Catalogue Number: SXPP1B415
• Device Lot Number: 101C9B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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