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

Device Problems Fracture (1260); Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Williksen, john h., md, et.Al, (2015) external fixation and adjuvant pins versus volar locking plate fixation in unstable distal radius fractures: a randomized, controlled study with 5-year follow-up.Journal of hand surgery american.Volume 40, page 1333 - 1340.This is for an unknown ao fixator nail/ unkown quantity/ lot # unknown.(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: williksen, john h., md, et.Al, (2015) external fixation and adjuvant pins versus volar locking plate fixation in unstable distal radius fractures: a randomized, controlled study with 5-year follow-up.Journal of hand surgery american.Volume 40, page 1333 - 1340.(norway).The purpose of this study is to determine whether volar locking plates (vlp) are superior to external fixation (ef) with adjuvent pins in unstable radius fractures after 5 years of follow-up.One hundred fourteen (114) patients with unstable distal radius fractures were assessed in this study.Three (3) were mistakenly included.Therefore, 2 were excluded postrandomization because of previous fractures to their ipsilateral wrist and 1 because of medical contraindications.Ultimately, 111 patients received their allocated intervention (59 in the ef group and 52 in the vlp group).The patients were followed at 2 weeks, 6 weeks, 4 months, 6 months, 12 months, and 66 months.At the 5 years follow-up, three (3) patients died and one patient experienced a fracture fixation failure.Forty-five (45) patients with 1 a2, 10 a3.23 c1, 9 c2, and 2 c3 fractures in the ef group, two (2) of which used a distal radius fixator.Ten (10) patients had secondary surgeries due to: - two patients (2) experienced carpel tunnel syndrome; - one patient had incomplete reduction; - one experienced a miscellaneous reaction; - five (5) had a scar correction.This report is one (1) of 3 for (b)(4).This report is for unknown ao fixator involving 10 patients who underwent secondary surgeries due to carpel tunnel syndrome, incomplete reduction, a miscellaneous reaction, and a scar correction.This report is for 1 device.

Manufacturer Narrative

Device code - no known device problem.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: APPLIANCE,FIXATION,NAIL
• 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: 6517946
• MDR Text Key: 73560365
• Report Number: 2520274-2017-11471
• Device Sequence Number: 1
• Product Code: KTT
• 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,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• 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: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention