MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ BI VIO 18IN2 USP1 D/A CTX; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B436
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and barbed suture was used.During the procedure, it was reported to the sales rep that the needle is keep pooping of the suture it happen three time a row with different patients and procedure.Product is not for return.No adverse patient consequences were reported.Additional information was 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H6 component code: g07002 - no device problem found.H3 investigation summary: the product was returned to ethicon for evaluation.Twelve representative unopened samples were received for analysis.Product code sxpp2b436.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 and examined along the strands and no anomalies were observed during evaluation.Functional test was performed using an instron equipment, and the pull force did not meet the minimum requirements in one sample.Further investigation was conducted on this sample, revealing that the end insertion of the suture did not meet the specified requirements.No anomalies were observed in the remaining eleven samples during the evaluation.Based on the information currently available, the short insertion issue was identified as pull out during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.H3 investigation summary: the product was returned to ethicon for evaluation.Two needle- suture pieces and one suture piece were received for analysis.Product code sxpp2b436; the product code is double armed.During visual inspection of the returned sample, the swage and attachment areas appeared as expected.However, marks consistent with contact from a surgical instrument were observed on the needle bodies, and one needle tip was bent.The suture pieces were attached to the needle barrel holes.Overall, no needle pull-off was observed.The sutures pieces were examined, and the extremes of the sutures were noted to be cut probably caused by a surgical instrument.In addition, body fluids were noted on the strands.The product code sxpp2b436 contains an absorbable suture.Since the samples were received open, the functional test could not be performed due to undetermined exposure to the environment.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no issues related to pull off - suture needle were noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional information was requested, and the following was obtained via: confirm whether the devices used in the three procedures were physically from lot 108xqb or from lot 103p0l.103p0l confirm whether any of the 14 devices from lot 103p0l exhibited the needle separation.Yes we have had multiples needle separations from the lot 103p0l.We sent those in because the surgeon no longer feels comfortable using this lot #.If available, please provide lot numbers for the actual devices used during each procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/21/2026.Corrected information: h6 investigational codes.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.

• Brand Name: SFX SPI PDS+ BI VIO 18IN2 USP1 D/A CTX
• 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: 24014177
• Report Number: 2210968-2026-00203
• Device Sequence Number: 9191450
• Product Code: NEW
• UDI-Device Identifier: 10705031464575
• UDI-Public: (01)10705031464575(17)270531(10)108XQB
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 08/31/2026
• Device Catalogue Number: SXPP2B436
• Device Lot Number: 103P0L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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