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

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

Patient Problem Unspecified Infection (1930)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-05474.Citation: https://doi.Org/10.1016/j.Wneu.2021.06.112.

Event Description

Title: timing of preoperative surgical antibiotic prophylaxis after primary one-level to three-level lumbar fusion.The purpose of this study was to examine the relationship between timing of preoperative surgical antibiotic prophylaxis and postoperative surgical site infections (ssis) among patients with 1-level to 3-level lumbar fusion.A retrospective cohort study was conducted among patients who underwent a primary 1-level to 3-level lumbar fusion at a single academic hospital between january 2013 and december 2017.Deep facial layers were closed with 1-0 vicryl sutures, subcutaneous layers were closed with 2-0 vicryl sutures, and the skin incision was closed with running 3-0 nylon sutures.Reported complications included surgical site infection (n=27).In conclusion results show that preoperative antibiotic administration beyond 1 hour in patients who have undergone lumbar fusion is associated with higher rates of ssi.

• Brand Name: 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: 15015738
• MDR Text Key: 295892650
• Report Number: 2210968-2022-05475
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• 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: 06/21/2022
• 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): Other