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

Catalog Number	SXPP1B456
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in (b)(6) 2026 and barbed suture was used.It was reported that the suture was broken when the surgeon attempted to sew the tissue.Total 2 products occurred suture breakage issue.Changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.According to sale rep's feedback, this hospital adopts the regular visiting process, the specific operation time and operator is unknown.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/23/2026.H6: component code: g07002: no device problem found.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.H3 investigational summary: the product was returned to ethicon for evaluation.One needle-suture piece outside its packaging was received for analysis.Product code sxpp1b456.During the initial inspection of the sample, no breakage of the suture was observed.Even though the extreme was noted to be cut and crimping marks were present on the surface, it was likely caused by a surgical instrument.The other section of the suture was not returned for analysis.The functional test was not possible because the suture was received with a short length.In addition, marks that appear to be caused by a surgical instrument were observed on the body needle.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.As with any device, care should be taken to avoid damage to the strand when handling.The event described could not be confirmed.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: 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24662447
• Report Number: 2210968-2026-02945
• Device Sequence Number: 18464041
• Product Code: NEW
• UDI-Device Identifier: 10705031240872
• UDI-Public: (01)10705031240872(17)260228(10)UCBDTS
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: 02/28/2026
• Device Catalogue Number: SXPP1B456
• Device Lot Number: UCBDTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2024
• 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