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 Fistula (1862); Pain (1994); Joint Dislocation (2374); Impaired Healing (2378); Unspecified Musculoskeletal problem (4535)

Event Date 05/30/2022

Event Type  Injury  

Event Description

Title: closing the gap: bridging peripheral sensory nerve defects with a chitosan-based conduit a randomized prospective clinical trial the purpose of this prospective randomized clinical experiment was to determine the efficacy of chitosan-based nerve conduits in regenerating sensory nerves in the hand.Forty -seven patients with peripheral nerve defects up to 26 mm distal to the carpal tunnel were randomized to receive either a chitosan conduit or an autologous nerve graft with the latter serving as the control group.Thirty three patients were assigned to the ang group and 24 to the cnc group.Males were mostly included in the study.After three months, self-reported pain scores on the visual nalogue scale ranged from 2.0 (ang) to 1.2 (cnc).After three months, patient satisfaction confirmed positive results.As a direct result of the cnc implementation, one patient developed a wound-healing disorder, which was accompanied by a dislocation and a small fistula of the cnc group.Autologous nerve graft (ang) was obtained from the medial or lateral cutaneous antebrachial nerve and coaptated end-to-end with 9-0 ethilon epineural stitches in a retrograde manner.The proximal and distal nerve ends of the intervention group (cnc) were cut back to expose healthy tissue.The chitosan-based nerve conduits (cnc) was then inserted and fixed to both nerve stumps using 9-0 ethilon 1¿2 epineural sutures, with cnc overlapping the nerve ends by about 2¿3 mm.Reported complications included injury(n=22), pain(n=?), wound-healing disorder(n=1), dislocation (n=1), small fistula (n=1).In conclusion, chitosan-based nerve conduits are safe and suitable for bridging nerve lesions up to 26 mm in the hand.Tactile gnosis improved significantly during the early regeneration period, and functional outcomes were similar to those obtained with an autologous nerve graft.Thus, chitosan appears to be a sufficient substitute for autologous nerve copyright: © 2022 by the authors.Grafts in the treatment of small nerve defects in the hand.

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: trial./.Pers.Med.2022, 12, 900.Https://doi.Org/10.3390/jpm12060900.

• 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: 18325487
• MDR Text Key: 330549086
• Report Number: 2210968-2023-09748
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 11/27/2023
• 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