MAUDE Adverse Event Report: OTTO BOCK HEALTHCARE LP OTTO BOCK AXTION® PROSTHETIC FOOT; 1E56 AXTION PROSTHETIC FOOT

Model Number 1E56=N28-5-P/0

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 03/13/2014

Event Type  malfunction  

Manufacturer Narrative

Recently otto bock healthcare lp performed a retrospective review across all products manufactured in (b)(4).During the review this malfunction was discovered and it was determined to be reportable based on the criteria outlined in 21 cfr 803.Device was never returned.

Event Description

The patient was wearing the foot during a pyramid break.The patient was said to have experienced an injury due to the pyramid breaking, but this was never able to be confirmed through communication requests.Out of an abundance of caution this complaint was reported as an mdr.

• Brand Name: OTTO BOCK AXTION® PROSTHETIC FOOT
• Type of Device: 1E56 AXTION PROSTHETIC FOOT
• Manufacturer (Section D): OTTO BOCK HEALTHCARE LP; 3820 west great lakes drive; west valley city UT 84120
• Manufacturer (Section G): OTTO BOCK HEALTHCARE LP; 3820 west great lakes drive; west valley city UT 84120
• Manufacturer Contact: caleb beck ; 3820 west great lakes drive; salt lake city, UT 84120 ; 8019746647
• MDR Report Key: 5813746
• MDR Text Key: 51022229
• Report Number: 1721652-2016-00006
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1E56=N28-5-P/0
• Device Catalogue Number: 1E56=N28-5-P/0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1