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 Problem Pain (1994)

Event Date 07/01/2022

Event Type  Injury  

Event Description

Title: failed acellular nerve allografts a critical review this study examines the acellular nerve allograft experience in a specialized peripheral nerve surgery department to discuss the clinical and histological findings in failed cases.Between (b)(6) 2015 and (b)(6) 2019, 8 patients identified to have failed acellular nerve allograft procedure were included in the study.This included procedures for 2 tibial nerves, 2 superficial radial nerves, 2 median nerves, 1 digital nerve and a lateral cord brachial plexus injury (male/female, 5:3; age range, 24¿54 years).All patients underwent microsurgical neurorrhaphy with fine monofilament interrupted sutures using 8/0 or 9/0 ethilon sutures (ethicon) in 6 patients, 6/0 prolene suture (ethicon) in 1 patient and a non-ethicon 8/0 nylon suture (manufacturer: unknown) in 1 patient.3 of these patients had fibrin glues adjunctive to the sutures.Reported complications included a 49-year-old male who had a neuroma proximal to the neurorrhaphy suture line (n=1) and a 34-year-old male who developed neuropathic pain (n=1).In conclusion, this article reports instances of acellular nerve allograft graft failure in a variety of contexts, for which the primary reasons for failure remain unclear.The etiology is likely to be multifactorial with both patient, graft and surgeon factors contributing to failure.Further clinical and histological analysis of acellular nerve allograft failures will improve our understanding of the mechanisms of graft failure.

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.Related events captured via: 2210968-2023-09496.Citation: ann plast surg 2022;89: 63¿71; https://doi.Org/10.1097/sap.0000000000003055.

• 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: 18271009
• MDR Text Key: 329775708
• Report Number: 2210968-2023-09497
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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: 11/14/2023
• 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
• Patient Age: 49 YR
• Patient Sex: Male