MalfunctionISH
FLEX-RUN WITH NIKE SOLE
Received Dec 22, 2020 · Event occurred Nov 2, 2020
Report 3003764610-2020-00002 · MDR key 11054853
Device
Product problems
- Break
- Therapeutic or Diagnostic Output Failure
Patient
42 YR
- Fall
- Concussion
- Fall
- Concussion
Narrative
Description of Event or Problem
PRODUCT FAILED TO PROVIDE SUPPORT WHEN CARBON BLADE BROKE BY BRITTLE FAILURE WHEN USER (SPORT ATHLETE) WAS SPRINTING AT APPROX 20 MPH, CAUSING HIM TO FALL. THE USER IS A SPORTS ATHLETE WITH IMPACT LEVEL EXTREME AND ACTIVITY LEVEL VERY HIGH. HE SUSTAINED A CONCUSSION AND WAS OFF TRAINING FOR A WEEK.