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

Initially an s1 service notification was created (500296911) for the axtion foot.The customer's description of the failure stated, "broken adapter".Administrators at (b)(4) returned the foot to (b)(4) on (b)(6) 2019 which reflects the actual reportable awareness date for (b)(4).S1 500296911 was immediately cancelled and s4 complaint notification was created (600561556).After follow up with the customer and end-user, it was determined this axtion foot was used within indications and the failure occurred during normal use.No fall or injury was reported by the end-user when this failure occurred.It could be argued this foot was used beyond intended use life but that cannot be explicitly confirmed with no on-board step counter in the mechanical, carbon foot.Evidence also confirms the possibility this foot was not returned as the instructions for use recommend when the initial signs of wear occurred (failure modes 01.001 and 04.001 are both user-fault).Regardless, a known design cause has been corrected for this failure (b)(4) and a newly designed pyramid has been implemented with absolute success in the market to date.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: 8601088
• MDR Text Key: 204066759
• Report Number: 1721652-2019-00003
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• 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=N28-5-P/0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2014
• 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 Age: 44 YR
• Patient Weight: 86