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

Catalog Number	SXPP1B420
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/1/2026 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: ¿ did this issue contribute to any patient adverse event? ¿ were there any unexpected outcomes or complications resulting from the prolonged surgery time? ¿ how long, in minutes, did the surgery prolong? ¿ which tissue was being sutured when the event occurred? ¿ was additional dissection required in other organs/tissues other than the target tissue? ¿ was there any change in the patient¿s post operative care due to the prolonged procedure? ¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) ¿ please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used.When using the barbed thread for a bypass, the surgeon realized that the thread did not hold.That is, he could remove it very easily.5 threads in a row.Notching is therefore not effective.Immediate action: removing the wire.In the end, after 5 wires, transition to v-lock.Consequence: waste of wire, loss of time, bothered surgeon, potential important patient risks.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 6/1/2026.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 ethicon for evaluation.One unused open sample was received for analysis.During the visual inspection of the returned sample, the suture was examined along the strand and no anomalies were observed during evaluation.Ten barbs were measured in the strand, and all barbs met the requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as 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: 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: 24757582
• Report Number: 2210968-2026-03374
• Device Sequence Number: 9376955
• Product Code: NEW
• UDI-Device Identifier: 10705031235809
• UDI-Public: (01)10705031235809(17)270731(10)10AH23
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K182873
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/21/2026

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: SXPP1B420
• Device Lot Number: 10AH23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 05/06/2026; 04/30/2026; 05/24/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/04/2026; 05/14/2026; 05/21/2026; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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