ICEROSS DERMO LOCKING

Additional Manufacturer Narrative

PRODUCT LIKELY FAILED TO PROVIDE SUSPENSION WHEN THE ATTACHMENT PIN DISCONNECTED FOR THE UMBRELLA OF THE LINER, WHEN THE USER WAS WALKING IN HIS HOME. FAILURE LIKELY OCCURRED DUE TO ABSENCE OF ADHESIVE AT THE THREADS ON THE ATTACHMENT PIN AND/OR INSUFFICIENT TORQUEING OF THE ATTACHMENT PIN. THE LIKELIHOOD OF THIS TYPE OF FAILURE LEADING TO A HAZARDOUS EVENT RESULTING IN A SERIOUS INJURY IS CONSIDERED PROBABLE. RISK RELATED TO THIS ISSUE HAS BEEN ASSESSED AND WEIGHED AGAINST BENEFITS OF THE DEVICE AND FOUND ACCEPTABLE. APPROPRIATE INFORMATION RELATED TO THIS RISK IS PROVIDED IN THE INSTRUCTIONS FOR USE FOR THE RESPECTIVE DEVICE. FURTHER ACTIONS ARE NOT CONSIDERED WARRANTED.

Description of Event or Problem

PATIENT WAS WALKING INDOORS WHEN THE SUSPENSION FAILED AND THE PROSTHESIS DETACHED FROM THE LEG. THE PATIENT FELL AND BROKE HIS ELBOW AND WAS PLACED IN CAST.

Description of Event or Problem

PATIENT WAS WALKING INDOORS WHEN THE SUSPENSION FAILED AND THE PROSTHESIS DETACHED FROM THE LEG. THE PATIENT FELL AND BROKE HIS ELBOW AND WAS PLACED IN CAST.