MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 27"(70CM) 2-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J266H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling (2091); Not Applicable (3189); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.The following additional information was received: the surgeon uses the 4 product codes on each joint procedure, unknown layer of tissue.The date of the procedure, and other details are not available.An unknown number of patients with drainage and unknown if drainage was cultured requiring additional procedure.No specifics are available at this time there are no additional details regarding the additional patient events.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.What was the date of the initial procedure? what tissue layer was each code of vicryl suture used on? what are the patient age, gender, weight, prior medical history? how was suture placed (continuous or interrupted)? what post op date did patient present with drainage symptoms? were any cultures taken of the wound drainage? what are the results of the cultures? what was the date of the second procedure? can you describe the appearance of each layer of tissue during the second procedure? what is the surgeon¿s opinion as to the contributing factor to the patient event? does the surgeon believe there was any deficiency in any code of the vicryl suture used? what is the patient current condition? note: events reported via 2210968-2019-81814, 2210968-2019-81817, 2210968-2019-81818, 2210968-2019-81819.
Event or Problem Description
It was reported that the patient underwent an orthopedic procedure on an unknown date and suture was used.Once the wound was starting to heal, the doctor reported buildup of fluid and necessary wound wash out being performed to clean affected area and reapproximate wound edges.Specific issues, such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing were possible but specifics weren't reported.Additional information has been requested.

• Brand Name: VICRYL SUTURE 27"(70CM) 2-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8638260
• Report Number: 2210968-2019-81817
• Device Sequence Number: 2211285
• Product Code: GAM
• UDI-Device Identifier: 10705031038370
• UDI-Public: 10705031038370
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: J266H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention