MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

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

Patient Problem Wound Dehiscence (1154)

Event Date 10/24/2021

Event Type  Injury  

Event Description

Title: comparison of 2-octyl cyanoacrylate skin adhesive and interrupted polypropylene sutures for wound closure in total ankle arthroplasty the aim of this prospective study was to compare wound complication rate, duration of surgery, length of hospital stay, and clinical outcomes between dermabond prineo and interrupted polypropylene sutures used for wound closure in patients undergoing total ankle arthroplasty (taa).Between january 2016 and december 2018, a total of 107 patients (108 ankles) with end-stage ankle arthritis underwent primary taa using competitor prostheses.In all patients, the anterior joint capsule and extensor retinaculum were repaired using 1¿0 braided absorbable sutures (vicryl, ethicon,somerville, nj ).The subcutaneous layer was repaired using suture from a competitor.The patients were divided into 2 groups according to the method of skin closure: 2-octyl cyanoacrylate and polymer mesh (dermabond prineo) were used in the skin adhesive group 36 patients, 36 ankles; 18 male and 18 female; mean age of 67.7 ± 7.1 (53 to 80) years; mean bmi of 26.5 ± 3.7 (18.1 to 34.3)], and interrupted polypropylene suture (3¿0 prolene, ethicon, somerville, nj) was used in the suture group [71 patients, 72 ankles; 33 male and 39 female; mean age of 67.1 ± 8.3 (49 to 86) years; mean bmi of 25.4 ± 2.9 (18.6 to 32.0)].The mean follow-up period was 38.7 ± 7.1 (18 to 48) and 35.3 ± 10.7 (20 to 61) months for skin adhesive group and suture group, respectively.Reported complications include wound dehiscence (n=5).Among these is a (b)(6) female patient with full incisional wound dehiscence who recovered by applying negative pressure wound therapy (npwt) without the need for further surgery.Another case progressed to a deep surgical site infection (n=1) and was successfully treated by revision taa in a two-stage procedure using an antibiotic-impregnated cement spacer.The rest of the patients healed with daily dressing and prolonged antibiotic use.The allergic contact dermatitis (n=1) in a (b)(6) female patient which progressed to deep surgical site infection with wound necrosis (n=1) despite wound care using negative pressure wound therapy (npwt) and prolonged intravenous antibiotic treatment.The patient recovered after repeated debridement and polyethylene liner exchange without implant removal; in addition, a local flap surgery was performed for the accompanying soft tissue necrosis.The superficial site infection (n=1) improved with antibiotic treatment and wound care without further surgery.In conclusion, although the use of dermabond prineo showed better patient satisfaction for wound cosmesis, there was a significantly high rate of overall wound complications, and there were no other benefits in terms of duration of surgery, length of hospital stay, and clinical outcomes compared to those with the use of interrupted polypropylene suture in taa.Our results suggest that careful vigilance is necessary when using dermabond prineo in taa.Further studies with larger samples are necessary to determine the effect of dermabond prineo in wound closure.

Manufacturer Narrative

(b)(4).Device not returned.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.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via mw# 2210968-2021-12582, mw# 2210968-2021-12584, mw# 2210968-2021-12585.Citation: citation: journal of orthopaedic surgery and research (2021);16(636):1-8.Https://doi.Org/10.1186/s13018-021-02791-x.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13002320
• MDR Text Key: 286432166
• Report Number: 2210968-2021-12583
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female