MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 18IN 1 SA OS-6; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A201
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # :(b)(4).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.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.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: * please confirm the number of procedures affected by this issue? 3 procedures * how many devices demonstrated the alleged deficiency on each involved patient/procedure? 3 units * when did the needle detach or pull off from the suture (in the package, during removal from the package, during handling prior to using on the patient, or during use on the patient)? during use on the patient, in the middle of the suture * were there any patient consequences? no * please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) (please refer the attached email).
Event or Problem Description
It was reported that a patient underwent an arthroplasty procedure on (b)(6) 2025 and barbed suture was used.During the procedure, according to the doctor's report, the thread is uncoiled from the needle.He has been using this thread for about 3 years and this problem has been occurring since (b)(6) 2025.I requested to store the next wire for analysis.There were no adverse reported.Additional information was requested.

• Brand Name: SFXSYM PDS+ UNI VIO 18IN 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: 21976291
• Report Number: 2210968-2025-04990
• Device Sequence Number: 9252658
• Product Code: NEW
• UDI-Device Identifier: 10705031227705
• UDI-Public: (01)10705031227705(17)260531(10)101REP
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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): 05/07/2025

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: 05/31/2026
• Device Catalogue Number: SXPP1A201
• Device Lot Number: 101REP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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