MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 9IN 0 SA CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A425
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
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.The following information was requested, but unavailable: when did the alleged deficiency occur (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? if different, please explain.Received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent knee joint replacement surgery on (b)(6) 2025 and barbed suture was used.The problem of pulling off suture needle happened in surgery.Changed to another one to complete the surgery.There were no adverse patient consequences reported.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/19/2026.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.H6 component code: c22 - photo analysis.Additional information: h3, h6.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 eth for evaluation.One detached needle and one used suture piece outside the foil packet were received for analysis.Product code sxpp1a425.Upon visual inspection of the returned sample, the swage and attachment area noted to be as expected.The barrel hole was examined under magnification, and no suture remnant was noted.The suture piece was examined, and the insertion end was observed to be as expected.The force used to detach the needle from the suture could not be determined.A photo was provided showing one detached needle and one suture inside a plastic bag and one foil packet that pertain to product code sxpp1a425.As part of the eth quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Per the conditions of the returned sample, no conclusion could be reached as to what caused the reported complaint.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: SFXSYM PDS+ UNI VIO 9IN 0 SA CT-1
• 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: 24060269
• Report Number: 2210968-2026-00439
• Device Sequence Number: 9494729
• Product Code: NEW
• UDI-Device Identifier: 10705031245129
• UDI-Public: (01)10705031245129(17)270131(10)106L04
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,Followup

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: SXPP1A425
• Device Lot Number: 106L04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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