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

Model Number 1E56=N27-4-P/0

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 12/02/2013

Event Type  malfunction  

Manufacturer Narrative

Recently otto bock healthcare lp performed a retrospective review across all products manufactured in (b)(4).During the review this malfunction was discovered and it was determined to be reportable based on the criteria outlined in 21 cfr 803.

Event Description

Patient: bilateral, (b)(6) kg, without warning the adapter broke and the patient fell.No injuries or harm reported.Location of the accident: at home.

• 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: caleb beck ; 3820 west great lakes drive; salt lake city, UT 84120 ; 8019746647
• MDR Report Key: 5809713
• MDR Text Key: 50936901
• Report Number: 1721652-2016-00005
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/18/2010
• Device Model Number: 1E56=N27-4-P/0
• Device Catalogue Number: 1E56=N27-4-P/0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 85