MAUDE Adverse Event Report: ETHICON INC. SFXSPI PDS+ BI VIO 6IN2 3-0 DA RB-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP2B431
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a robotic-assisted laparoscopic radical prostatectomy on (b)(6) 2025 and a barbed suture was used.During the procedure, before suturing, when it was tried to start suturing by holding with the robotic arm, the needle and suture were detached like a control release needle.It was not a control release needle.The product was not used for the patient.Another like device was used, there were no adverse consequences to the patient.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 device not returned attempts have been 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.Additional information was requested, and the following was obtained: another product was used to complete the case.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.Can you identify the lot number of the product used?.
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 was requested, and the following was obtained: we got this info from the actual product on (b)(6) 2025.-lot number tcbhxu.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/14/2025.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.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 ethicon for evaluation.One empty foil, one paper lid, one suture piece, a detached needle and one small needle- suture were received for analysis.Product code sxpp2b431, this product code is double armed.During the visual inspection of the detached needle, the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined with magnification, and no suture remnant was noted.The suture piece was examined, and on one extreme, a correct insertion mark was observed; however, the force used to detach the needle from the suture could not be determined.Also, some damaged (crushed) on the surface probably caused by a surgical instrument.Besides that, body fluids were noted along the strand.In the inspection of the needle-suture piece, the swage and attachment area were noted to be as expected, and no needle pull off was noted.The suture was examined, and the extreme was noted to be cut probably caused by a surgical instrument.The functional test was not possible because the suture was received with a short length.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: SFXSPI PDS+ BI VIO 6IN2 3-0 DA RB-1
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21317861
• Report Number: 2210968-2025-01423
• Device Sequence Number: 15627573
• Product Code: NEW
• UDI-Device Identifier: 10705031464735
• UDI-Public: (01)10705031464735(17)250228(10)TCBHXU
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2025

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: 02/28/2025
• Device Catalogue Number: SXPP2B431
• Device Lot Number: TCBHXU
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 02/06/2025; 03/18/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/06/2025; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2023
• 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