MAUDE Adverse Event Report: ETHICON INC. 6 4-18 " STEEL MONO V-40; SUTURE, NONABSORBABLE, STEEL

Catalog Number M649

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

Patient Problem Insufficient Information (4580)

Event Date 08/03/2021

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.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.(b)(4).Citation: https://doi.Org/10.1177/03000605211041265.

Event Description

Title: comparison of polyetheretherketone cables and stainless steel wires for sternal fixation after median sternotomy.The objective of this study is to compare the sternal fixation effect of a polyetheretherketone (peek) cable product and stainless steel wire after median sternotomy.A multicentre retrospective clinical trial was conducted in patients that underwent median sternotomy for a range of surgical reasons.The sternum was fixed using peek sternal cables in the experimental group and stainless steel wires in the control group.A total of 108 patients (54 in each group) were included in the analysis at the final 180-day follow-up.Stainless steel wires (m649; ethicon, raritan, nj, usa) was used.Reported complications included one patient in the control group that experienced subcutaneous lipoliquefaction at day 7 postoperatively and was discharged after effective therapies.In conclusion peek cables are easy to implant and show desirable effectiveness in sternal fixation without any observed side-effects.

Manufacturer Narrative

(b)(4) date sent to the fda: 12/27/2022 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.The following information was requested but unavailable: 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?.

• Brand Name: 6 4-18 " STEEL MONO V-40
• Type of Device: SUTURE, NONABSORBABLE, STEEL
• 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: 16006145
• MDR Text Key: 305730318
• Report Number: 2210968-2022-10409
• Device Sequence Number: 1
• Product Code: GAQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2022
• 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