MAUDE Adverse Event Report: ETHICON INC. GUT CHROMIC SUTURE; SUTURE, ABSORBABLE, NATURAL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Wound Dehiscence (1154); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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 the ethicon suture product involved caused and/or contributed to the postoperative complications described in the article? does the surgeon believe there was any deficiency with the ethicon suture products used in this procedure?.

Event Description

It was reported in a journal article entitled: synovial fistula as a complication of recurrent dorsal wrist ganglion excision: case report author(s): nash h.Naam, md citation: hand surg 2012;37a:1225¿1228; doi:10.1016/j.Jhsa.2012.02.015 the author presented a (b)(6) right handed female patient who underwent excision of a recurrent left dorsal wrist ganglion through a transverse incision.In the procedure, the wound was closed with 4-0 chromic and 4-0 prolene sutures.Two weeks later, the surgeon noticed dark discoloration and separation of wound edges and this was closed again with 4-0 prolene sutures.Two weeks later, sutures were removed, but the wound dehisced and again wound was closed with prolene sutures.Ten days later, the wound started to drain frothy fluid and the surgeon excised the wound edges and closed the wound with nylon sutures.Several factors were likely responsible for occurrence of the fistula.One of the factors is likely to be the technique used in the excision of the recurrent ganglion.Wrist exploration at the time of fistula excision demonstrated that a large segment of the dorsal capsule of the wrist had been excised with the ganglion.Steroids following excision of the recurrent ganglion might have contributed to the wound dehiscence, which started the process of fistula development.

• Brand Name: GUT CHROMIC SUTURE
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7623880
• MDR Text Key: 111828931
• Report Number: 2210968-2018-73612
• Device Sequence Number: 1
• Product Code: GAL
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR