MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ BI VIO 14IN2 USP1 D/A MO-4; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B400
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).H3 investigation summary: the product was returned to ethicon for evaluation.One open box with twelve unopened samples were received for analysis.The product code sxpp2b400 is a double armed.In order to evaluate the condition of the returned samples, the packets were opened.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems.Additionally, each sample was evaluated by measuring 10 barbs per suture.The results revealed that out of the 12 sutures analyzed, 7 samples did not meet the specified requirements for the barb measurements.Based on the information currently available, barbs out specification were identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information: was surgery delayed due to the reported event? --> no, was procedure successfully completed? --> yes, were fragments generated? --> no, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> no, 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 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.¿ what was the name of the procedure? ¿ what was the procedure date? ¿ was the ¿missing barbs¿ noted during visual inspection or during use on patient? ¿ did the barbs fail to engage in the tissue? ¿ please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq).
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2025 and barbed suture was used.During the procedure, was alerted by clinic nurse that dr experienced 2x faulty sxpp2b400 where barbed suture was totally smooth and unable to catch onto tissue.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/22/2025.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.Corrected information: b3.Additional information was requested; the following was obtained: what was the name of the procedure? total knee replacement.What was the procedure date? unknown, around mid (b)(6).Was the ¿missing barbs¿ noted during visual inspection or during use on patient? 1st pc during use on patient, 2nd pc was during visual inspection before use on patient.Did the barbs fail to engage in the tissue? yes.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) on dd mmm yyyy or provided from knowledge as you were present in the case? (b)(6), clinic nurse manager.
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.Additional information: h7, h9.

• Brand Name: SFX SPI PDS+ BI VIO 14IN2 USP1 D/A MO-4
• 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
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22610495
• Report Number: 2210968-2025-08617
• Device Sequence Number: 9603768
• Product Code: NEW
• UDI-Device Identifier: 10705031464568
• UDI-Public: (01)10705031464568(17)260930(10)104DBB
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K192144
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2025

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: 09/30/2026
• Device Catalogue Number: SXPP2B400
• Device Lot Number: 104DBB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 08/05/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/22/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3017102971-08/19/25-002-
• Patient Sequence Number: 1
• Patient Sex: Unknown