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 Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

[(b)(4)].

Event Description

It was reported by the end-user's facility that the end-user was simply performing normal daily activities.While walking, the end-user heard a pop and observe that his axtion foot pyramid had cracked through.No fall or injury resulted from the axtion pyramid failure.Therefore, no medical attention was sought after this failure.The axtion foot could no longer be used and the defect was reported to ottobock one week after the event.All information reported back from the end-user's facility confirmed that the foot was used as instructed and within proper indications.The failure occurred within the intended use-life for this device.Out of an abundance of caution, this complaint is being reported as an mdr since this confirmed failure has demonstrated the risk of causing serious injury to the 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: 8204284
• MDR Text Key: 131718784
• Report Number: 1721652-2018-00004
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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=N26-3-P/0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2013
• 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
• Patient Weight: 100