InjuryISH
VARI-FLEX MODULAR
Received May 8, 2014 · Event occurred Apr 2, 2014
Report 3003764610-2014-00002 · MDR key 3815616
Device
Product problems
- Component Falling
- Device Slipped
Patient
Not reported
- Fall
- Loss of consciousness
Narrative
Description of Event or Problem
BELOW KNEE AMPUTEE PATIENT WAS WALKING WHEN THE PROSTHESIS BECAME UNLOCKED. THE LEG FELL OFF CAUSING HER TO FALL INTO A RETAINING WALL. SHE WAS KNOCKED UNCONSCIOUS.
Additional Manufacturer Narrative
CONCLUSION: WE NEED THIS ICELOCK 400 TO PERFORM FURTHER INVESTIGATION FOR THE ROOT CAUSE FOR THIS INCIDENT. WHEN RECEIVED THIS RA FORM 219 WILL BE UPDATED. IN PROJECT (B)(4) THE SURFACE TREATMENT OF BOTH LOCKING WASHER AND THE PIN WAS CHANGED TO PREVENT THIS TO HAPPEN. ALSO IT IS VERY IMPORTANT TO CHANGE THE LOCKING PIN AS RECOMMENDED IN IFU A LEAST YEARLY.