MAUDE Adverse Event Report: SMALL BONE INNOVATIONS, INC. START TOTAL ANKLE REPLACEMENT`

Model Number 400-254

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

Patient Problems Arthritis (1723); Arthralgia (2355)

Event Date 10/08/2014

Event Type  Injury  

Event Description

Start total ankle replacement talar component was exchanged to correct sizing issue.The sliding core mobile bearing was also exchanged.

Manufacturer Narrative

Additional removed components: sliding core mobile bearing; model#: 400-142; lot#: 0945163; expiration date: 01/01/2015; device manufacture date: 01/2010.Visual examination of explants show insignificant wear and evidence of good osseointegration.There were no deviations reported in the dhrs either part no.(b)(4), lot no.0913039, and part no.(b)(4), lot no.090303/0252.All released parts were within specification.

• Brand Name: START TOTAL ANKLE REPLACEMENT`
• Manufacturer (Section D): SMALL BONE INNOVATIONS, INC.; morrisville PA 19067
• Manufacturer Contact: steve ward ; 1380 s. pennsylvania ave.; morrisville, PA 19067 ; 2153376481
• MDR Report Key: 4218710
• MDR Text Key: 5002669
• Report Number: 3003640913-2014-00083
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: 400-254
• Device Lot Number: 091015/0713
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR