MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, BONE

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: grutzner, p.A.Et al (2005).Computer-assisted liss plate osteosynthesis of proximal tibia fractures: feasibility study and first clinical results.Computer aided surgery, 10, 141-149.This report is for an unknown unreamed tibia nail / unknown quantity / unknown lot.(b)(4).The investigation could not be completed and 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 the subsequent review of the following literature article, grutzner, p.A.Et al (2005).Computer-assisted liss plate osteosynthesis of proximal tibia fractures: feasibility study and first clinical results.Computer aided surgery, 10, 141-149.The authors presented a consecutive case study regarding reality-enhanced virtual fluoroscopy with radiation-free updates of in situ surgical fluoroscopic images to control long-bone fracture reduction.The study consisted of three male patients, (38 to 61 years of age), with four fractures of the proximal tibia who presented between june and august 2001.The patients were primarily fixed with an external fixator or synthes unreamed tibia nailing (utn) and secondarily stabilized with synthes less invasive stabilization system (liss).All patients were in follow-up for 18 months.Results included a (b)(6) male with a proximal tibial fracture, association for the study of internal fixation (ao) c1 remaining instability and varus deformity after treatment with utn four months before.The patient underwent removal of utn and treatment with 13 hole liss.After treatment with the liss plate, there were no complications and the patient experienced uneventful healing.This is report 1 of 1 for (b)(4).This report is for an unknown unreamed tibia nail.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6068879
• MDR Text Key: 58816493
• Report Number: 2520274-2016-15132
• Device Sequence Number: 1
• Product Code: JDS
• 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: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• 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: 61 YR