MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(4).This report is for an unknown 95 degree blade plate/unknown quantity/unknown lot.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 hanson,t.W.& cracchiolo, a.(2002).The use of a 95 degree blade plate and a posterior approach to achieve tibiotalocalcaneal arthrodesis.Foot and ankle international 23(8):704-710.United states.A retrospective review of adult patients who had undergone a tibiotalocalcaneal fusion using a synthes, (b)(4) 95 degree blade was done between april 1995 and june 2000.The review included 10 adults (five men and five women).The average age of the patients was (b)(6) with an age range of 42 to 80 years.Six patients were diagnosed with post-traumatic arthritis, two with primary degenerative arthritis, one with rheumatoid arthritis, and one with post-polio deformity prior to surgery.The patients were having this surgery due to pain and/or deformity that has not responded to non-surgical and other surgical treatments.Fusion was achieved clinically and radiographically in all patients.After the completion of the surgery one patient complained of pain on a daily basis.This is report 2 of 2 for (b)(4).This report is for an unknown 95 degree angled blade plate.(b)(6).

• Type of Device: APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• 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: 5631668
• MDR Text Key: 44408007
• Report Number: 2520274-2016-12459
• Device Sequence Number: 1
• Product Code: KTW
• 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: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• 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: 04/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention