MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A OS-6; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A201

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a knee procedure in 2022 and barbed suture was used.It was reported by the sales that post-op to the total knee procedure that while the patient was at home, they pulled the device out of their knee.They came back in the office three months later for a routine follow up and the patient was fine.The doctor stated they have been having a series of problems with the device.In the last four to five months, they have been getting abscess reactions.They stated it was not all the time but ten percent of the time in small areas where they have seen where small portions of the suture did not absorb.Additional information was requested.

Manufacturer Narrative

(b)(4).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.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.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.Please confirm who pulled the device out of the patient's knee: it was reported that the doctor stated they have been having a series of problems with the device, could you please provide more details? it was reported that ten percent of the time in small areas where they have seen where small portions of the suture did not absorb, what is the total number of procedures? what is the total number of products involved in this event? did the event occur during one or multiple patient procedures? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If this event occurred in multiple procedures, please provide the following information for each patient event.What was the name of the procedure? what was the procedure date? was there any adverse consequence associated with the patient? please provide the lot number: device return status: trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m.

Manufacturer Narrative

Product complaint # (b)(4).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.Additional information was requested, and the sales rep provided the following information: i have spoke with dr.(b)(6) and we are going to continue to monitor his pa¿s closure technique.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A OS-6
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16127032
• MDR Text Key: 308638997
• Report Number: 2210968-2023-00220
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227705
• UDI-Public: 10705031227705
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A201
• Device Catalogue Number: SXPP1A201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2023
• 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