MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

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

Patient Problems Wound Dehiscence (1154); Erythema (1840); Hematoma (1884); Unspecified Infection (1930); Scar Tissue (2060); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.Additional information was requested, and the following was obtained: does the surgeon believe there was any deficiency with the ethicon products (vicryl plus, ethibond and unknown ethicon absorbable knotless barbed running sutures) involved? does the surgeon believe that ethicon products (vicryl plus, ethibond and unknown ethicon absorbable knotless barbed running sutures) involved caused and/or contributed to the post-operative complications described in the article? were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number for each patient (n=(b)(6) female with bmi of 27.13 kg/m2; n=(b)(6) male with bmi of 27.65 kg/m2; and n=(b)(6) male patient with bmi of 30.72 kg/m2)? were there any treatments provided for n=60/66 events with worst imaginable scar? all information request above are unknown.Citation: bmc musculoskeletal disorders (2020) 21:178; https://doi.Org/10.1186/s12891-020-03205-5.Events for (b)(6) male patient with bmi of 30.72 were submitted via 2210968-2020-04964, 2210968-2020-04965.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: tissue adhesive for wound closure in enhanced-recovery total hip arthroplasty: a prospective, randomized and controlled study.This prospective, randomized and self-controlled study aimed to present the experience of adopting tissue adhesive as adjunct to standard wound closure in total hip arthroplasty (tha) and evaluate its role and cost performance.From (b)(6) 2019 to (b)(6) 2019, a total of 30 patients (n=17 male, n=13 female; median age: (b)(6) years; mean bmi 22.94 kg/m2) were enrolled in the study.For standard wound closure, the following were used for different layers: joint capsule and external rotator muscles were reconstructed with 2¿0 ethibond non-absorbable suture w4843 (ethicon).Deep fascia and superficial fascia were sutured with 2¿0 absorbable knotless barbed running suture and 4¿0 coated vicryl plus antibacterial interrupted suture (ethicon).Subcuticular tissue was closed with 4¿0 absorbable knotless barbed running suture (ethicon).Complaint included prolonged wound drainage in standard wound closure side in 3 patients (n=(b)(6) female with bmi of 27.13 kg/m2; n=(b)(6) male with bmi of 27.65 kg/m2; and n=(b)(6) male patient with bmi of 30.72 kg/m2).Treatment of the patients included re-suture and oral antibiotics.Wound-related evaluation scores reported for patient scar assessment score (psas) is 30.57 (mean score) and n=60/66 represents worst imaginable scar; and vancouver scar score (vss) is 5.77 (mean score).In conclusion, tissue adhesive could significantly reduce wound drainage and increase patients¿ satisfaction, which can be an ideal adjunct to standard wound closure in enhanced recovery tha.

Manufacturer Narrative

Date sent to the fda: 11/25/2020.Additional h-6 health effect - clinical codes: e171601, e0505, e2340,e1906.Additional h-6 health effect - impact code: f19.Additional b5 narrative: wound-related complications included redness, dehiscence, subcutaneous hematoma, prolong wound drainage (> 5 days), surgical site infection (ssi) and re-suture caused by any reasons.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.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10212537
• MDR Text Key: 199086914
• Report Number: 2210968-2020-04966
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• 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: 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR