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

Catalog Number	SXPP1A405
Medical Device Problem Codes	Material Separation (1562); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used.The primary package of the suture was found damaged prior to planned use.Besides, upon opening the packaging for inspection, the problem of pulling off suture needle had happened.Changed another one to complete the surgery.There is no report on patient's injury.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 number, and no related non-conformances were identified.Additional information was requested, and the following was obtained: were there any issues with the seal of the sterile packaging? no.Do you have any photos available for visual analysis? no.Please describe the damaged primary package: please refer to the event description, other information requested is unknown.Was the sterility of the device compromised due to the damaged packaging? no.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: it was reported that the procedure was performed (b)(6) 2026.According to the lot number provided - tkmhrk / sxpp1a405, the expiration date is aug/31/2025.Please confirm the product was expired at the time it was opened.Please confirm this was not used on the patient.Investigation summary: the product was returned to eth for evaluation.Visual inspection showed one detached needle and one suture outside the foil packet were received for analysis.Product code sxpp1a405.During examination, a short insertion length was observed at the suture end, and no remnant was found within the needle barrel hole.Visual inspection determined that the needle and suture were detached due to the suture insertion did not meet the specified acceptance criteria.The foil packet was visually inspected, and wrinkles were observed on the cavity.The condition of the package is indicative of handling and storage issues that occurred outside of ethicon control.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.
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 h6 type of investigation.
Additional Manufacturer Narrative
Product complaint # (b)(4).The following information was requested, but unavailable: it was reported that the procedure was performed (b)(6) 2026.According to the lot number provided - tkmhrk / sxpp1a405, the expiration date is aug/31/2025.-please confirm the product was expired at the time it was opened.--received information as following from sales rep via phone; confirm that the product was expired at the time it was opened and not used on the patient.-please confirm this was not used on the patient.--received information as following from sales rep via phone; confirm that the product was expired at the time it was opened and not used on the patient.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.

• 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.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24533135
• Report Number: 2210968-2026-02328
• Device Sequence Number: 16036690
• Product Code: NEW
• UDI-Device Identifier: 10705031227682
• UDI-Public: (01)10705031227682(17)250831(10)TKMHRK
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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 Expiration Date: 08/31/2025
• Device Catalogue Number: SXPP1A405
• Device Lot Number: TKMHRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 04/06/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/03/2026; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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