MAUDE Adverse Event Report: ETHICON INC. ETHILON BLUE NYLON SUTURE; SUTURE, NONABSORBABLE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Numbness (2415); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If the device or further details are received at the later date a supplemental medwatch will be sent.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethilon nylon suture contributed to the adverse events described in the article, specifically: infection, numbness , antibiotics? please provide details of event and specific suture product type.Provide product codes and lot numbers.Can specific patient demographics be provided for each of the subjects relating to adverse events in this article? if yes, please include: date of procedure, where procedure was performed, specific medical/surgical intervention per patient, product involved, pre-existing conditions.Are the product code and lot numbers available for devices used?.

Event Description

It was reported in a journal article that the patient underwent an arthroscopic anterior cruciate ligament/ acl reconstruction with quadrupled semitendinosus tendon autograft on unknown date and the suture was used to close the skin.Following the procedure, the patient possibly experienced complications included superficial wound infection at the tibial fixation site and was treated with antiseptic dressings and oral antibiotics for one week.It was possible that the patient experienced numbness over the anterior aspect of leg.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 08/16/2017.

• Brand Name: ETHILON BLUE NYLON SUTURE
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6716421
• MDR Text Key: 80116897
• Report Number: 2210968-2017-32956
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: No
• 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