inforMED
MalfunctionISH

OTTO BOCK AXTION® PROSTHETIC FOOT

Received Dec 8, 2017 · Event occurred Nov 14, 2017

Report 1721652-2017-00006 · MDR key 7101800

Device

Generic name

1e56 Axtion® Prosthetic Foot

Model number

1E56

Catalog number

1E56=N27-5-P/0

Product problems

  • Fracture
  • Fracture

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE END-USER WAS USING THE AXTION FOOT DURING NORMAL GARDENING ACTIVITIES WHEN THE PYRAMID ADAPTER SNAPPED IN HALF. NO FALL OR INJURY OCCURRED AS A RESULT OF THE DEVICE FAILURE. THE END-USER'S FOOT WAS WITHIN THE WARRANTY PERIOD AND THE FOOT WAS BEING USED AS INTENDED BY THE MANUFACTURER. OUT OF AN ABUNDANCE OF CAUTION, THIS COMPLAINT WILL BE REPORTED AS AN MDR SINCE THIS CONFIRMED DEVICE FAILURE IS KNOWN TO HAVE THE POTENTIAL TO CAUSE SERIOUS INJURY.

Remedial action

  • Replace