MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 24IN 1 SA OS-6; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A203
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) h6.Investigation findings: c22 ¿ photo investigation.H6 component code: g07002 - device not returned.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.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.Additional information was requested, and the following was obtained via: were there patient consequences? no -please provide the title of external person providing answers to follow-up.Nurse(ortho ot technician) additional h11: was surgery delayed due to the reported event? unknown, was procedure successfully completed? yes, were fragments generated? no, if yes, were they removed easily without additional intervention? no, patient status/ outcome / consequences , was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4), device property of none, device in possession of none.H3: photo investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos show an open foil labeled as sxpp1a203 and two winding formers with an apparent needle detachment.A clear analysis of the end point of failure or the needle hole could not be performed due to the position of the needle.Based on the photo review, the event reported is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.
Event or Problem Description
It was reported that a patient underwent an angioplasty procedure on (b)(6) 2025 and barbed suture was used.During the procedure, stratafix symmetric pds plus suture has been detached from needle after the initial bite.Same has happened for another suture also.Two foils has been complaint.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SFXSYM PDS+ UNI VIO 24IN 1 SA OS-6
• 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: 23348907
• Report Number: 2210968-2025-12087
• Device Sequence Number: 18527926
• Product Code: NEW
• UDI-Device Identifier: 10705031245198
• UDI-Public: (01)10705031245198(17)260831(10)103KL8
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K141776
• 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
• Report Date (Section B): 10/21/2025

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: 08/31/2026
• Device Catalogue Number: SXPP1A203
• Device Lot Number: 103KL8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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