MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL UNKNOWN; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

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

Patient Problems Erythema (1840); Pain (1994); Scar Tissue (2060); Swelling/ Edema (4577)

Event Date 10/01/2019

Event Type  Injury  

Event Description

Title: clinical application of continuous reinforced intradermal suture in hip and knee joint replacement incisions.The aim of this study was to investigate the clinical efficacy of reinforced continuous intradermal suture in hip and knee joint replacement incisions.A total of 73 patients (80 incisions) undergoing hip or knee joint replacement were enrolled from march to august in 2017 including 48 hip incisions and 32 knee incisions considered as continuous suture group.The continuous suture was used for the closure of skin and fat layer of these incisions with 2-0 absorbable barbed suture (stratafixspiral, johnson & johnson).3-4 needles of intermittent intradermal suture with the use of 2-0 absorbable suture (vicryl plus, johnson & johnson) with big distance to reinforce the position of low tension.In another cohort, a total of 65 patients (71 incisions) including 42 hip incisions and 29 knee incisions were selected from september 2016 to february 2017 considered as intermittent suture group and all the incisions were closed by intermittent suture using 2-0 absorbable suture (vicryl plus, johnson & johnson).In both group, deep suture treatment of surgical wound was performed after prosthesis placement in hip and knee arthroplasty using 2-0 absorbable suture (vicryl plus, johnson & johnson) was selected to perform interrupted suture of muscle and fascia layer by poking catheter drainage beside the incision.The patients in continuous suture group were followed up for 6-11 months, with an average one of (8.2 ± 1.5) months; the patients in interrupted suture group were followed up for 6-11 months, with an average one of (7.8 ± 1.6) months.Reported complications include: in the continuous suture group, mild redness, swelling and pain around the incision and 3 ~ 4 days after operation (n=6) and the symptoms subsided after moderate squeezing and extrusion of liquefied fat; small part of the epidermis blackening of the incision, with an average width of 3.2 mm (n=3) which was replaced by new epidermis after 1 month of follow-up; small range of skin edge opening after dressing change on the 2nd day after operation (n=2) which was closed by dressing compression bandaging and postoperative routine guidance of joint activities; and scar hyperplasia (n=4).In the interrupted suture group, redness where the suture entered and exited the skin (n=8) which was improved after removing the stitches for incision healing; mild redness, swelling and pain around the incision (n=7) and the symptoms subsided after extrusion of more liquefied fat; small part of skin edge necrosis of the incision with an average width of 3.7 mm (n=4) which was improved and healed after dressing change; small range of skin edge opening after dressing change on postoperative d2 ~ 3 days (n=4) which was closed after dressing change; and scar hyperplasia (n=8).In conclusion, the reinforced continuous intradermal suture is safe and reliable for hip and knee joint replacement incisions which can bear the tension from wide-range activities of hip or knee joint, have small scar and satisfied cosmetic result.

Manufacturer Narrative

(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Component code: (b)(4) device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-05658.Citation: chinese journal of bone and joint surgery (2019);12(10):782-805.Doi: 10.3969/j.Issn.2095-9958.2019.10.08.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 2360 ¿g/m.

Manufacturer Narrative

(b)(4).Date sent to the fda: 7/29/2022.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 information was requested but unavailable: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics?.

• Brand Name: STRATAFIX SPIRAL UNKNOWN
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15057977
• MDR Text Key: 296213870
• Report Number: 2210968-2022-05659
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 07/29/2022
• 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