MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 9IN USP0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B455
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2025 and barbed suture was used.During the procedure, stratafix suture broke/frayed while suturing vaginal cuff.Surgeon grasped suture with instrument/needle driver/grasper as per usual practice and suture broke.Grasper checked for sharp edges and none noted.No adverse patient consequences were reported.Additional information was requested.
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.Additional information was requested, and the following was obtained via: site complaint # (b)(4) \n\nsxpp1b455 - suture frayed and broke while suturing vaginal cuff and grasped with a needle driver - regular practice.Driver/ grasper was inspected for sharp edges as potential cause.None noted.Site pulling lot# off shelf.See attached image with complaint description and site details.\n\n sfx spi pds+ uni vio 9in usp0 s/a ct-1 - sxpp1b455 (sxpp1b455): not applicable\nlist any j&j products that were utilized during the case but did not contribute to the reported event.Grasper - type not noted \nwas there any reported patient or user harm? no \nwas there a significant delay? no \nif available, provide the product order number (po).\ndo, you need product packaging to send the product back? no \nwould you like a return label at the end of this process? yes \nthis parcel contains biohazardous materials and/or materials used during a medical procedure.Yes , "eventdescription": "site complaint #(b)(4) \n\nsxpp1b455 - suture frayed and broke while suturing vaginal cuff and grasped with a needle driver - regular practice.Driver/ grasper was inspected for sharp edges as potential cause.None noted.Site pulling lot# off shelf.See attached image with complaint description and site details.\n\nsfx spi pds+ uni vio 9in usp0 s/a ct-1 - sxpp1b455 (sxpp1b455): not applicable\nlist any j&j products that were utilized during the case but did not contribute to the reported event.Grasper - type not noted \nwas there any reported patient or user harm? no \nwas there a significant delay? no \nif available, provide the product order number (po).\ndo you need product packaging to send the product back? no \nwould you like a return label at the end of this process? yes \nthis parcel contains biohazardous materials and/or materials used during a medical procedure.Yes ", "pcassociatedcontacts": [ h3 investigation summary: the product was returned to eth for evaluation.Two empty foil packets and one needle suture piece were received for analysis.Product code sxpp1b455.During visual inspection of the returned sample, the swage and attachment area were observed to be as expected.The suture piece was examined, and the ends were noted to be split likely caused by a surgical instrument.No anomalies or issues related to breakage suture was observe during the evaluation.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 eth quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what caused the reported complaint.Additional h11: was surgery delayed due to the reported event? unknown, action taken when event occurred? not described, was procedure successfully completed? yes, were fragments generated? unknown, 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 ofnone, device in possession of none.

• Brand Name: SFX SPI PDS+ UNI VIO 9IN USP0 S/A 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: 23926711
• Report Number: 2210968-2025-14702
• Device Sequence Number: 9012865
• Product Code: NEW
• UDI-Device Identifier: 10705031240834
• UDI-Public: (01)10705031240834(17)261231(10)105P0Q
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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): 12/30/2025

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: SXPP1B455
• Device Lot Number: 105P0Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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