MAUDE Adverse Event Report: ETHICON INC. STRATAFIX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B413
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).H6 type of investigation: b21 - device evaluation pending.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.The device upon which this medwatch is based has been received, however, the product 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, and no non-conformances were identified.Additional information was requested, and the following was obtained via: - were there any unexpected outcomes or complications as a result of the prolonged surgery time? no - was there any change in the patient¿s post-operative care due to the prolonged procedure? no - were there any patient consequences? no - please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).(b)(6).,rep, on behalf of dr (b)(6), gyn - 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.Shipped fed ex on friday, (b)(6) 2026 ¿ tracking number:(b)(4).
Event or Problem Description
It was reported that a patient underwent a robotic ovarian cystectomy procedure on (b)(6) 2026 and barbed suture was used.During the procedure, it was reported to the sale rep that during a robotic ovarian cystectomy procedure the surgeon completed excision of the ovarian cyst and began closing the ovary.While performing the closure with stratafix, the suture began to slip and unravel, despite the surgeon having executed two back passes in accordance with standard technique.Due to the suture not maintaining hold, the surgeon elected to switch to a competitive product to complete the closure.This resulted in additional operative time being required to successfully finish the case.Device is available for return.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.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: h6, d9, h3.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one used needle-suture piece was received for analysis.The product code sxpp1b413.During the visual inspection of the returned sample, marks that appear to be caused by a surgical instrument were observed on the body needles.The suture pieces were examined, and the extreme was noted to be cut, and some crimping marks were present on the surface, it was likely caused by a surgical instrument.As per the condition of the sample, the barbs could not be measured and the functional test could not be performed.Given the current condition of the returned sample, it is not possible to determine the potential cause of the reported event.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on the cause of the reported event.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: STRATAFIX
• 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: 24666205
• Report Number: 2210968-2026-02968
• Device Sequence Number: 20094268
• Product Code: NEW
• UDI-Device Identifier: 10705031236165
• UDI-Public: (01)10705031236165(17)270831(10)10B5UM
• 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,Followup
• Report Date (Section B): 04/20/2026

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: SXPP1B413
• Device Lot Number: 10B5UM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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