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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
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.Additional information was requested and the following was provided: when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.Stratafix needle came off during vaginal vault closure (normal use).Returning unused boxes of lot# 2 opened (21 eaches).Needle that came off suture was accidently discarded by scrub tech, just sterile samples of same lot # being returned.Was surgery delayed due to the reported event? no, was hysterectomy successfully completed? yes, this would indicate needle came off while suturing - closure of vaginal cuff/valut.So during use on patient.How many devices demonstrated the alleged deficiency? in this instance just 1.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a laparoscopic hysterectomy in (b)(6) 2025 and barbed suture was used.The needle came/pop off the strand during vaginal vault closure (normal use).The needle that came off suture was accidently discarded by scrub tech, just sterile samples of same lot # being returned.There were no adverse patient consequences and the procedure was successfully completed without delay.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/4/2026 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.H6 component code: g07002 no device problem found additional information: h3, h6 h3 investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that two opened boxes with a total of twenty (20) unopened samples that pertains to product code sxpp1b455 were received for analysis.As per the sampling plan, a visual inspection was performed on thirteen samples.The packets were opened and the swage and attachment area were noted to be as expected in all needles.The sutures were dispensed without problems and examined along the strand no anomalies were observed during evaluation.A functional test was performed using instron equipment, and the pull force results were above the minimum requirements.The device performed without any defect noted.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the devices were returned without detectable damage.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24030406
• Report Number: 2210968-2026-00231
• Device Sequence Number: 21058530
• 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,Followup

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: 01/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/05/2026
• 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