MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 9IN 0 S/A V-34; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B457

Device Problem Positioning Failure (1158)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Component code: g07002 - device not returned.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.The following additional information was received: surgeon began trialing stratafix in (b)(6) 2022 in her robotic hysterectomy procedures.Initial feedback was that she appreciated the less pronounced barbs over her current vloc configuration and she liked the sharpness of the taper cut needle.We discussed that with the design of our suture she may have to take a couple of passes before seeing it lock into place.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: was there any intervention required? was there any patience consequences? what is the date of this procedure? what is the lot number? 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.Trade name - irgacare.Active ingredient(s) - triclosan.Dosage form - suture/solid/parenteral.Strength - 2360 g/m.

Event Description

It was reported that a patient underwent a hysterectomy procedure in (b)(6) 2022 and barbed suture was used.During use the surgeon commented that the suture seemed to slip back and didn¿t seem to grab the tissue.She terminated the suture by taking at least two passes in the opposite direction.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 3/23/2023.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.H6 component code: g07002 no device returned.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, the following was obtained: was there any intervention required? one patient required to go to ed for bleeding.One patient with spotting.Was there any patience consequences? yes.What is the date of this procedure? unknown.What is the lot number? unknown.

• Brand Name: SFX SPI PDS+ UNI VIO 9IN 0 S/A V-34
• Type of Device: 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16456047
• MDR Text Key: 310411022
• Report Number: 2210968-2023-01370
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031240896
• UDI-Public: 10705031240896
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1B457
• Device Catalogue Number: SXPP1B457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1