MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI 12IN 4-0 SA PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B112

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

Patient Problems Abscess (1690); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: (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.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 g/m (b)(4) - device not returned.To date it has been reported that the device will not be returned.If the device or further details are received as 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 provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Please provide the onset date/time of infection from the initial surgical procedure.Were there any pre-existing signs/symptoms of active infection or inflammation prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.How much and what type of drainage is present in this wound? please describe any medical/surgical intervention performed including medication name and results.Other relevant patient history/concomitant medications? were any pre-op cleansing procedures or products changed recently? if yes, please describe.Does the patient have a known allergic history to any medical devices, food and/or medication? was allergy testing performed? if so, please describe with results.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot number? surgeon¿s name?.

Event Description

It was reported that a patient underwent a total knee arthroplasty on an unknown date and barbed suture was used on the dermis.Post-op, approximately 4 weeks post-op, the distal end of the knee at the end of the suture became inflamed and did not heal smoothly.The patient experienced stitch abscess and inflammation.Because the end of suture was closed, there was a possibility that it also affected.The surgeon stated that when the suture was removed from the area where the pus had come out and the wound was fixed at 2 or 3 points with steri-strip, the inflammation subsided quickly.The surgeon opined that the event may not have been caused by the suture, but it may be necessary to be aware that the tensile strength of the suture is long and remains long.It may be important to suture the area not too close to the skin.Additional information was requested.

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 following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure? unknown.Date of index surgical procedure? unknown.The diagnosis and indication for the index surgical procedure? unknown.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? other.Total knee arthroplasty.On what tissue was the suture used? dermis.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unknown.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure? unknown.Was at least one reverse stitch performed prior to closure? unknown.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? not reported.Please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Suture site abscess.Please provide the onset date/time of infection from the initial surgical procedure.No further information is available.Were there any pre-existing signs/symptoms of active infection or inflammation prior to this surgical procedure? not reported.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? no.Were cultures performed? if so, please provide the results.Unknown.How much and what type of drainage is present in this wound? unknown.Please describe any medical/surgical intervention performed including medication name and results.Removal of suture and used skin tape.Then relieved.Other relevant patient history/concomitant medications? unknown.Were any pre-op cleansing procedures or products changed recently? if yes, please describe.Unknown.Does the patient have a known allergic history to any medical devices, food and/or medication? unknown.Was allergy testing performed? if so, please describe with results.Unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? dr.Said it may not be due to the thread, but it may be necessary to be aware that pds has a long tensile strength and remains for a long time.It may be important to suture where it is not too close to the skin.What is the patient's current status? the sumpton was relieved.Lot number? unknown.Surgeon¿s name?.

• Brand Name: SFX SPI PDS+ UNI 12IN 4-0 SA PS-2 PRM MP
• 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: 15821357
• MDR Text Key: 303898430
• Report Number: 2210968-2022-09588
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031235984
• UDI-Public: 10705031235984
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K150670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPP1B112
• Device Catalogue Number: SXPP1B112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/03/2023
• 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): Other