MAUDE Adverse Event Report: ETHICON INC. SFXSPI MCL+ BI VIO 6IN2 3-0 DA RB-1; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP2B416
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).Date sent to the fda: 7/25/2025.H6 component code: g07002 - no device problem found.H6 component code: c22 - photo analysis.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.Additional information was requested, the following was obtained: - did the reported issue contribute to any patient adverse consequences? - could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided - please provide the source or name of person providing answers to follow-up questions: no known patient consequence, just surgeon frustration.H3 investigational summary: the product was returned to ethicon for evaluation.One unused strand double armed outside its packaging was received for analysis.Product code sxmp2b416.In addition, a photo was provided, and it showed one foil packet, lot tdbhlx, product code sxmp2b416.During the visual inspection of the returned sample, the barbs were observed in the suture.In addition, ten barbs were measured in the strand, and all barbs met the requirements.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 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 complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent a robot assisted prostatectomy procedure in (b)(6) 2025 and barbed suture was used.It was reported that during a robot assisted prostatectomy, the surgeon felt that the suture strand did not adequately hold the tissue approximated for the uva.They were unable to see the barbs under the magnification of the scope.The strand in question is not available for return, but a strand from the same box is available for analysis.Surgical delay was unknown.No patient was reported.Additional information was requested.

• Brand Name: SFXSPI MCL+ BI VIO 6IN2 3-0 DA RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22621108
• Report Number: 2210968-2025-08618
• Device Sequence Number: 8932561
• Product Code: GAM
• UDI-Device Identifier: 10705031465114
• UDI-Public: (01)10705031465114(17)250331(10)TDBHLX
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K192580
• 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
• 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: 03/31/2025
• Device Catalogue Number: SXMP2B416
• Device Lot Number: TDBHLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2023
• 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