MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 12IN 0 S/A V-34; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B404

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a total knee procedure on an unknown date in 2022 and barbed suture was used.Post-op, the patient had necrotic wound.Current patient status unknown.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Additional information has been requested and the following was received.If further details are received at a later date a supplemental medwatch will be sent.No additional information is available at this time.In what area or tissue was the severe necrotic tissue? patient experienced a mild case of necrosis, no additional information is available at this time.Is photo available of patient's necrosis? no.What was the procedure date? not provided.Were any cultures taken? results? unknown.Patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) unknown name of surgeon? dr.(b)(6) current patient status.Unknown.In the manner the stratafix was used on each patient, is it believed to have contributed to necrosis? our belief is that the way the stratafix was ¿double backed¿ could have caused strangulation of the tissue which resulted in the necrosis.In the manner the stratafix was used on each patient, is it believed to have contributed to some other issue, please specify? (no response).No product is available for return.Note: events reported on: mw# 2210968-2023-00431, mw# 2210968-2023-00432, mw# 2210968-2023-00434.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 ¿g/m.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.

Manufacturer Narrative

Product complaint # (b)(4).Additional information; h6.Health effect - impact code.Note: events reported on: mw# 2210968-2023-00431, mw# 2210968-2023-00433, mw# 2210968-2023-00434, mw# 2210968-2023-00453.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.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+ UNI VIO 12IN 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16216914
• MDR Text Key: 307837881
• Report Number: 2210968-2023-00432
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031236073
• UDI-Public: 10705031236073
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150670
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPP1B404
• Device Catalogue Number: SXPP1B404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2023
• 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
• Patient Outcome(s): Required Intervention