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 Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 05/31/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products involved: dermabond advanced, dermabond prineo, monocryl suture, caused and/or contributed to the post-operative complications described in the article: mesh group: infection, wound drainage / suture group :wound drainage? does the surgeon believe there was any deficiency with the ethicon products (dermabond advanced, dermabond prineo, monocryl suture) used in this procedure? 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.Events reported on mw# 2210968-2021-07666, mw# 2210968-2021-07668.Citation: arthroplasty today 9 (2021) 83e88.Https://doi.Org/10.1016/j.Artd.2021.04.016.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: a single-center randomized prospective study investigating the efficacy of various wound closure devices in reducing postoperative wound complications.Author: simon greenbaum, md a, stephen zak, ba a, paul j.Tesoriero, md a, hayeem rudy, md a, jonathan vigdorchik, md b, william j.Long, md frcsc a, ran schwarzkopf, md, ms a.Citation: arthroplasty today 9 (2021) 83e88.Https://doi.Org/10.1016/j.Artd.2021.04.016.This study aims to compare operative wound closure times as well as perioperative outcomes, complications, and costs associated with zipper technology, synthetic absorbable monofilament suture plus skin adhesive, and monofilament with polyester mesh plus skin adhesive after tka and total hip arthroplasty (tha).Between february 2017 and may 2018, 160 patients who were elected to undergo primary tka or tha were recruited for this study.In this tja cohort, 61 were tha patients while 99 were tka patients.All participants¿ surgical wounds were closed with one of the 3 newer treatment devices, either zipper (zip surgical skin closure; zipline medical inc, (b)(4)), synthetic absorbable subcuticular monofilament suture (monocryl; ethicon, (b)(4)) plus skin adhesive (dermabond advanced; ethicon, (b)(4)), or the same subcuticular monofilament suture with a polyester mesh skin adhesive system (dermabond prineo; ethicon, (b)(4)).For the polyester mesh closure, the mesh is laid over the wound, and an oca preparation specific to this system is painted over the wound and mesh.Although the manufacturer recommends that this system may be applied without running a subcuticular suture, our practice is to use the mesh over a wound closed with running monofilament suture.There were 54 (17 males, 37 females) age 65.48 ± 13.85, 55 (21 males,34 females) age 63.6 ± 12.71 and53 ( 19 males and 34 feamles) age 61.49 ± 8.75 patients in the zipper, suture, and mesh groups, respectively who underwent tha + tka.Reported complications included: mesh group : infection (n=1), wound drainage, which may require secondary surgical intervention (n=3).Suture group: wound drainage, which may require secondary surgical intervention (n=5).It was concluded,that while the suture group trended toward shorter closure times in this study, there were no significant differences in our secondary outcome complication rates.We therefore looked to an additional secondary outcome, cost.The cost differential between these techniques is therefore the major distinguishing characteristic we found.The costs must be considered by each institution individually because the exact cost is different for each hospital or system, and the cost savings may or may not be considered a reason enough to deviate from a preferred closure.

• 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: 12365985
• MDR Text Key: 268087711
• Report Number: 2210968-2021-07667
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• 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: 07/28/2021
• 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