VARI-FLEX
Received May 27, 2024 · Event occurred Apr 4, 2024
Report 3003764610-2024-00003 · MDR key 19400969
Product problems
- Fracture
- Insufficient Device Problem Information
- Fracture
- Insufficient Device Problem Information
Patient
NA · Unknown
- Laceration(s)
- Limb Fracture
- Laceration(s)
- Limb Fracture
Narrative
Description of Event or Problem
USER WAS ON A MOTOR CYCLE AND WAS NOT ABLE TO BRAKE. HE FELL AND FRACTURED HIS RIGHT HAND AND GOT A LACERATION ON THE RIGHT KNEE.
Description of Event or Problem
USER WAS DRIVING A MOTOR VEHICLE AND WAS NOT ABLE TO BRAKE. HE GOT IN AN ACCIDENT AND FRACTURED HIS RIGHT HAND AND GOT A LACERATION ON THE RIGHT KNEE.
Additional Manufacturer Narrative
THE TOP CARBON BLADES SNAPPED AT THE ADAPTER; THE RIGHT BLADE SHOWED NO DELAMINATION, AND THE LEFT BLADE HAD MINOR DELAMINATION. IT IS CONCLUDED THAT THE INJURIES AND PRODUCT FAILURE WERE A RESULT OF THE CRASH. THE FAILURE CLOSELY RESEMBLES THE RESULTS OF THE DROP TESTS INVOLVING SUDDEN IMPACT OF EXTREME FORCE FOCUSED ON THE TOE AREA. THE PRODUCT HAD BEEN IN USE FOR ONLY 11 DAYS BEFORE THE INCIDENT. THE LIKELIHOOD OF THIS TYPE OF FAILURE LEADING TO A HAZARDOUS EVENT RESULTING IN A SERIOUS INJURY IS CONSIDERED REMOTE. FURTHER ACTIONS ARE NOT CONSIDERED WARRANTED.