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); Unspecified Infection (1930)

Event Date 09/27/2023

Event Type  Injury  

Event Description

Title: the hand and wrist: antimicrobials and infection (hawaii) trial.The aim of this prospective, multicentre, randomized, controlled feasibility trial was to evaluate feasibility for a definitive trial.Secondary objectives were incidence of ssi in both groups, hand function measured with patient-reported outcome measures, health-related quality of life and change in employment.Patients aged 18 years or older with any hand or wrist injury requiring an operation that included the use of sutures were eligible for inclusion.From 10 march 2022 to 2 november 2022, 116 participants were randomly assigned to receive either antimicrobial sutures (n = 60; 46 were males; intervention group) or standard sutures (n = 56; 36 were males; control group) alone.Follow-up for the primary outcome was completed in january 2023 and final follow-up was completed in may 2023.The mean age was 44.8 (17.5) years and 47.2 (20.0) years for intervention and control group, respectively.The intervention arm received antimicrobial sutures produced by ethicon (for example, monocryl plus, pds plus).Antimicrobial sutures could be deployed alone or in combination with standard sutures, and for any part of the operation (for example, deep structural repair, skin closure).The control arm received standard, non-antimicrobial sutures of any kind as per standard practice at each site.Reported complications include wound dehiscence (n=?).Based on the bluebelle wound healing questionnaire (bwhq), occurrence of surgical site infection in the intervention group at 30 days was (n=8) and (n=8) at 90 days.In conclusion, risk of ssi after hand trauma is high.A definitive rct of antimicrobial sutures in hand trauma surgery is feasible, if retention is improved.

Manufacturer Narrative

(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.Citation: bjs, 2023, 110, 1774¿1784.Https://doi.Org/10.1093/bjs/znad298.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• 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: 18350579
• MDR Text Key: 330816457
• Report Number: 2210968-2023-09882
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/18/2023

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
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/18/2023
• 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