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

Model Number 1E56

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported by the end-user's facility that, "pyramid broke - cracked at the bolts." after multiple attempts to gather additional information, the customer was non-responsive.No information is known about how the foot was used, events leading up to the failure, and if anything significant resulted after the failure occurred.The failure did occur within the intended use life of the specified foot.Out of an abundance of caution, this complaint is being reported as an mdr since the confirmed failure has historically caused serious injury to an end-user.

• 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: stephen anderson ; 3820 west great lakes drive; west valley city, UT 84120 ; 8019746676
• MDR Report Key: 8430620
• MDR Text Key: 139213189
• Report Number: 1721652-2019-00001
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1E56
• Device Catalogue Number: 1E56=N29-4-P/0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1