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 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

Submission was originally attempted on 11/13/2018.It was discovered on 11/13/2018 that the original submission was not accepted due use of an incorrect icsr version.Icsr r2 is now required.I re-installed esubmitter in hopes the problem is resolved and my submission will be accepted.The cdrh emdr help desk suggested the re-installing of the esubmitter would resolve this issue.(b)(4).

Event Description

The end-user was walking into a movie theatre and heard a crack.Immediately the end-user realized the pyramid adapter had cracked causing the foot to become disconnected from their pylon.The end-user avoided falling and was able to get back to his home safely.He used a back up foot until his axtion foot was replaced.No fall or injury resulted.All information reported by the customer and end-user indicates 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: 8071584
• MDR Text Key: 129188015
• Report Number: 1721652-2018-00003
• 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: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• 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=N29-5-P/0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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: 120