MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

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

Patient Problems Erythema (1840); Post Operative Wound Infection (2446); Blister (4537); Insufficient Information (4580)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.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? which specific ethicon products have been used during the procedures (product code, lot number)? 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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2024-03576 and 2210968-2024-03577.Citation: journal of wound care vol 32, no 2, february 2023/ https://doi.Org/10.1136/bmj.C1199.

Event Description

Title: staples versus sutures wound closure in hip and knee arthroplasty: a prospective cohort study.The objective of this study is to compare two methods of wound skin closure¿staples versus vertical mattress nylon sutures¿in patients undergoing primary total hip (thr) and total knee replacements (tkr).Between september 2018 to september 2019, a total of 100 patients met the inclusion criteria.In the staples group (n=50), 26 patients underwent thr while 24 patients underwent tkr.In the sutures group (n=50), 23 patients underwent thr and 27 patients underwent tkr.The sex distribution of all patients was 80% (n=80) females and 20% (n=20) males.Regarding wound complications, no major wound complication was reported up to six-weeks postoperatively.In total, nine patients in the sutures group (three thr and six tkr) and six patients in the staples group (two thr and four tkr) had minor wound complications such as skin redness, warmth, small blisters and superficial wound infections due to retained stitch or staple.The methods of wound closure were either interrupted vertical mattress nylon sutures (3-0 ethilon nylon suture, us) or staples (covidien appose ulc autosuture slim body skin stapler 35 w, us).The medial parapatellar approach for tkr and the direct transgluteal approach for thr were used.The subcutaneous layer was closed by vicryl 0 suture for all patients.Reported complications included minor wound complications such as skin redness, warmth, small blisters and superficial wound infections (n=9).In conclusion, in thr and tkr, there was no significant difference between either vertical mattress nylon sutures or staples primary skin closure in terms of wound complications and patient satisfaction in this study.The decision on wound closure method should be based on the availability of resources in the institution/country.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 18998978
• MDR Text Key: 338881351
• Report Number: 2210968-2024-03577
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: K946173
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 03/08/2024
• 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