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 Wound Dehiscence (1154); Unspecified Infection (1930); 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.Citation: the iowa orthopaedic journal; 30 (167).(b)(4).

Event Description

It was reported via journal article: title: "modification of the sinus ta rsi approach for open reduction and plate fixation of intra-articular calcaneus fractures: the limits of proximal extension based upon the vascular anatomy of the lateral calcaneal artery." authors: john e.Femino, md, tanawat vaseenon, md, david a.Levin, md, edward h.Yian, md.Citation: the iowa orthopaedic journal; 30 (167).The goal of operative treatment of calcaneal fractures is to obtain the best possible reduction of the articular surfaces and restoration of the architecture of the non-articular portions of the bone, and to hold this reduction with stable internal fixation.The authors retrospectively reviewed 13 patients (12 male and 1 female patient; age range: 26 to 71 years old) who had undergone open reduction and lateral plate fixation without bone graft of closed displaced intraarticular calcaneus fractures using an extensile sinus tarsi approach.During the surgical procedure, the skin is closed in 2 layers with nurolon 3-0 or 4-0 absorbable sutures (ethicon).A gauze dressing is placed with a bolster, and a dressing of abd pads is placed over the foot and ankle with an a-o style splint 16 using modest molding over the lateral wall to augment compression.Reported complications included one patient with wound dehiscence and infection which was salvaged by below-knee amputation and one patient with sustained lateral wound dehiscence due to hematoma which was healed uneventfully after surgical debridement, closure, and subsequent local care.It was reported that the extended sinus tarsi approach provides good exposure to the calcaneus for reduction and fixation and also provides exposure for concomitant treatment of injuries to the lateral ankle and talus.The incision can be extended to allow access to the distal tibia and fibula, talus, and the lateral column of the foot.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7986420
• MDR Text Key: 124502536
• Report Number: 2210968-2018-76670
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention