MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE FIXATION DEIVCE

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Rogachefsky, r.(2001).Treatment of severely comminuted intra-articular fractures of the distal end of the radius by open reduction and combined internal and external fixation.The journal of bone and joint surgery, 83-a (4) 509-519.This report is for an unknown ao external fixator with 4.0/3.0-mm schanz pins/unknown quantity/unknown lot.(other number) udi: unknown part number, udi is unavailable.(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: rogachefsky, r.(2001).Treatment of severely comminuted intra-articular fractures of the distal end of the radius by open reduction and combined internal and external fixation.The journal of bone and joint surgery, 83-a (4) 509-519.This is a retrospective study of severely comminuted intra-articular fractures by the distal end of the radius treated with open reduction and internal fixation.There were 17 patients of the original 25 patients available for follow-up and included in the study.There were fourteen men and three women who ranged in age from 27-59 years, with a mean age of 43 years.Eleven fractures required a dorsal buttress plate and/or a volar buttress plate, and eleven required bone grafting.An unknown system consisting of an ao external fixator with 4.0/3.0-mm schanz pins was used in sixteen patients.In addition, a 3.5-mm distal radial plate was used in eleven fractures.Complications included: one patient experienced reflex sympathetic dystrophy and underwent implant removal.This is report 2 of 3 for (b)(4).This report is for an unknown ao external fixator with 4.0/3.0-mm schanz pins.

• Type of Device: APPLIANCE FIXATION DEIVCE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5413631
• MDR Text Key: 37568330
• Report Number: 2520274-2016-10848
• Device Sequence Number: 1
• Product Code: JDO
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/05/2016
• 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