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 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Multiple attempts to seek information regarding the specific event(s) surrounding this failure were unsuccessful.Regardless of these attempts, a fall or injury was never reported or confirmed as this complaint was being handled.The customer reported information that the foot was being used within indications.Weight, activity level, and normal activities (walking on "road, path, meadow at home") reported were all well within this foot's intended use.This failure occurred within the intended use-life for this foot.Out of an abundance of caution, this complaint is being reported as an mdr since this confirmed device 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: 8071245
• MDR Text Key: 127361958
• Report Number: 1721653-2018-00002
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/13/2018

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=N27-3-P/0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• 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: 78