MAUDE Adverse Event Report: SYNTHES USA; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Arthritis (1723); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Date of event: computer hexapod-assisted orthopaedic surgery for the correction of tibial deformities.The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after subsequent review of the following literature article: hughes, a; et al (2016) computer hexapod-assisted orthopaedic surgery for the correction of tibial deformities.J orthop trauma, 30:7, e256-e261.The purpose of this study was to present the clinical and radiological results of the first sequential series of patients undergoing deformity correction and stabilization using the computer hexapod-assisted orthopaedic surgery (chaos) technique for deformities of the tibia.All underwent acute intraoperative correction through single or multiple osteotomies mediated by the taylor spatial frame before definitive internal stabilization using a locked intramedullary nail.Deformity correction and restoration of the tibial mechanical axis was achieved in all cases.Thirteen consecutive tibial chaos procedures were performed in 12 patients with a mean age of 34.7 years at the time of surgery.Six were male patients and 6 were female patients, with a mean duration of follow-up of 19 months.Definitive stabilization was achieved with a trigen metanail ((b)(4)) in 11 cases, with the remaining patient receiving stabilization with an ao expert nail ((b)(4)).All patients went on to achieve clinical and radiological union at all osteotomy sites.No patients required further intervention to achieve union.The cause of the tibial deformity was malunion of a tibial fracture in 4 cases, ostegenesis imperfecta in 2 cases, vitamin d-resistant rickets (vdrr) in 3 cases, with the remaining cases attributable to spondyloepiphyseal dysplasia and neurofibromatosis type 1.It is not the standard practice in our unit to remove implants following union.However, patient 5 with malunion tibial fracture developed posttraumatic arthritis of the ankle treated by fusion of the ankle following removal of the intramedullary nail.In all cases, there was an improvement in both the anteroposterior and lateral mechanical axes of the tibia.This report is 1 of 1 for (b)(4).This report is for an unknown ao expert nail and refers to the serious injury of patient 5, (b)(6) who experienced posttraumatic arthritis treated by fusion of the ankle following removal of the intramedullary nail.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6306155
• MDR Text Key: 66655956
• Report Number: 2520274-2017-10401
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• 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?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR