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

Catalog Number	SXPP1A405
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.¿ when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify --during use on the patient a manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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.
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used.The problem of pulling off suture needle happened in surgery.Changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.The needle did not fell into the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/9/2026.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.Additional information: d9, 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.Visual inspection revealed that several suture pieces and one labeled winding former with a detached needle were received for analysis.Product code sxpp1a405.During visual inspection of the detached needle, the swage and attachment area was noted to be as expected.The barrel hole was examined, and remnant of suture was observed.The suture was examined, and it was found that it has begun the degradation process which caused the needle to come out from the suture.In addition, the foil packet was not returned for evaluation.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the conditions of the sample received, no conclusion could be reached as to what caused the reported complaint.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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 18IN 1 SA CT
• 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: 24521442
• Report Number: 2210968-2026-02289
• Device Sequence Number: 13184542
• Product Code: NEW
• UDI-Device Identifier: 10705031227682
• UDI-Public: (01)10705031227682(17)270331(10)10800C
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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 Catalogue Number: SXPP1A405
• Device Lot Number: 10800C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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