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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment not diagnosis.This report is for an unknown tomofix system.(b)(4).Investigation could not be completed and no conclusion could be drawn, as no devices were returned and no lot numbers or part numbers were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the subsequent review of the following journal article: dexel, j., fritzsche, h., beyer, f., harman, m., lutzner, j.(2015) open-wedge high tibial osteotomy: incidence of lateral cortex fractures and influence of fixation device on osteotomy healing.Knee surg sports traumatol arthrosc.The purpose of this study was to evaluate osteotomy healing after fixation with two different locking plates.Between 2003 and 2012, a total of 69 medial open-wedge high tibial osteotomy (hto) were performed on patient with medial compartment knee osteoarthritis and varus malalignment.After achieving the preoperatively designated leg axis correction, the osteotomy was fixed with an internal plate fixator with locking screws, either the tomofix (synthes, oberdorf, switzerland) implant from april 2003 until september 2009 or the position hto maxi plate of a competitor from july 2009 until december 2012.Screw loosening occurred in 2 patients.This report is for an unknown tomofix system.This is report 2 of 2 for (b)(4).

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5890257
• MDR Text Key: 52737229
• Report Number: 2520274-2016-14252
• Device Sequence Number: 1
• Product Code: HWC
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• 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