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 Codes	Positioning Failure (1158); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unspecified orthopedic procedure in 2025 and barbed suture was used.The particular piece of suture has an unusually smooth surface, with the bard not deep enough to provide proper holding strength compared the other sutures.Upon opening the packaging, he immediately noticed the difference by touch, as the suture felt much smoother than usual.There were no adverse patient consequences reported.Additional information has been requested.
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.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.Are there photos available for visual analysis? what is the procedure name and date? please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).Attempts are being made to retrieve the device.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 number, and no related non-conformances were identified.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: h6, d9, h3.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that one unused needle suture combination present in two sections outside the winding former was received for analysis.The product code sxpp2b400 is double armed.Upon visual inspection of the returned sample, the swage and attachment area were noted to be as expected in the needles.The suture pieces were examined, and the barbs did not meet the requirements.Based on the information currently available, barbs out of specification was identified during the investigation of the sample received.This product issue will be addressed through eth quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Additional information was requested, and the following was obtained via: 1.Are there photos available for visual analysis? ans: defect product complaint already courier to you.2.What is the procedure name and date? ans: total knee replacement, exact date was unsure but is in (b)(6) 2025.3.What is the source of information for the queries above (e.G., answered by the physician / provided from knowledge as you were present in the case).Ans: provided by head of purchaser from ot staff.

• 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: 23851649
• Report Number: 2210968-2025-14379
• Device Sequence Number: 18534824
• Product Code: NEW
• UDI-Device Identifier: 10705031464568
• UDI-Public: (01)10705031464568(17)260331(10)100KA2
• Combination Product (Y/N): Y
• Initial Reporter Country: MY
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Expiration Date: 03/31/2026
• Device Catalogue Number: SXPP2B400
• Device Lot Number: 100KA2
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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