MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930)

Event Date 03/18/2022

Event Type  Injury  

Event Description

Title: early mobilization versus bed rest for incidental durotomy: an institutional cohort study.The purpose of this retrospective cohort study was to assess whether flat bed rest > 24 hours after a primarily repaired incidental durotomy improved outcomes by decreasing the need for revision surgery related to csf leak or wound infection and whether prolonged bed rest after durotomy was a risk factor for medical and wound complications and longer hospital length of stay (los).Of the 420 incidental durotomies identified from the operative report between january 2010 and november 2020, a total of 361 patients who underwent primary repair of their durotomy were included in the study.Primary repair of the dura was achieved with a 6-0 prolene, 4-0 silk, or 4-0 nurolon suture.Some patients underwent augmentation of their repair with dural onlay applied directly to the suture-repair site followed by application of a sealant or fibrin glue.The type of suture used for closure of the incidental durotomy and the decision to augment the repair were based on the preference of the treating surgeon.There were 254 patients (130 were males; average age was 61 years) in the = 24-hour bed rest group and 107 patients (53 were males; average age was 60 years) in the > 24-hour bed rest group.Reported complications include csf leak requiring reoperation/repair (n=?) and infection requiring washout (n=?).In conclusion, in this retrospective study, the rate of revision surgery was not higher in patients with durotomy who underwent immediate mobilization, and medical complications were significantly decreased.Flat bed rest > 24 hours following incidental durotomy was associated with increased length of stay and increased rate of medical complications.After primary repair of an incidental durotomy, flat bed rest may not be necessary and appears to be associated with higher costs and complications.

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? if available, please provide the exact number of patients who had csf leak and infection associated with the use of ethicon devices (6-0 prolene or 4-0 nurolon suture) as the article did not specify it per device.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.Related events reported via 2210968-2023-03265.Citation: j neurosurg spine (2022); 37:460¿465.Https://doi.Org/10.3171/2022.1.Spine211208.

• Brand Name: NUROLON 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: 16864987
• MDR Text Key: 314509884
• Report Number: 2210968-2023-03264
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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: 04/26/2023
• 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
• Treatment: UNKNOWN SILK SUTURE.
• Patient Outcome(s): Required Intervention