| Insecure attachment of handlebar clamp resulting in downward shift of system |
Compromised steering, stability, and balance — potential damage to secondary clamp |
8 |
Material failure from over-torquing or extreme stress; improper user assembly |
4 |
Torque testing, inspection of clamp prior to use |
1 |
32 |
Include expected bolt lifespan and detailed inspection instructions in the IFU |
| Braking lever attachment plate not secure on top tube |
Unable to apply rear brakes; distracts user from the road; brake line falls and entangles pedals, gears, or the user's leg/foot |
10 |
Velcro fatigue failure, brake material degradation, or insufficient tightening |
5 |
Physical testing after installation and prior to use; inspection for wear |
2 |
100 |
Include extensive setup and inspection guidelines in the IFU |
| User unable to disengage from cuff (stuck in cuff) |
User injury including skin irritation, skin tear, tissue damage, or broken arm |
10 |
Top opening too narrow, change in limb size, or cuff material too stiff |
1 |
Fit testing before and after installation and prior to use |
2 |
20 |
Include testing as an IFU step; design top opening with a safe width |
| Primary (handlebar) clamp fracture |
Primary attachment point for the affected limb fractures |
10 |
Bolt fracture or stripping from over-torquing; nylon lock-nut fatigue |
1 |
Physical testing prior to riding; visual inspection of nuts and bolts |
3 |
30 |
Include regular inspection guidance and a replacement schedule in the IFU |
| Secondary (stem) clamp fracture or deformation |
Primary clamp becomes susceptible to rotation; risk of device damage or user injury |
10 |
Wear and tear, excessive stress, incorrect installation, or improper storage |
3 |
Stability testing; inspection of clamp prior to use |
4 |
120 |
Include regular clamp inspection and storage guidelines in the IFU |
| Scaffolding fracture or deformation |
Limb attachment disconnects from handlebars; forces user into a non-ideal riding position; possible fall into handlebars |
10 |
Wear and tear, excessive stress, incorrect installation, or improper storage |
3 |
Stability testing; inspection of scaffolding prior to use |
5 |
150 |
Include scaffolding inspection prior to every use and storage guidelines in the IFU |
| Telescoping tube-to-stem clamp fracture or deformation |
Primary clamp susceptible to rotation; impacted steering control; broken structure could interfere with the user |
8 |
Wear and tear, excessive stress, incorrect installation, or improper storage |
3 |
Testing and inspection of telescoping tubes prior to use |
4 |
96 |
Include inspection of the secondary attachment arm and storage guidelines in the IFU |
| Insufficient brake line tension |
Inability to apply rear brakes; distracts user from the road |
7 |
Wear along the exposed brake line, loosened crimp, or improper installation |
2 |
Brake force testing; fully depress the brake line prior to use |
1 |
14 |
Include brake line security inspection and strict IFU tightening guidance |
| Knee brake lever fracture or deformation |
Inability to apply rear brakes; brake line could fall and entangle pedals, gears, or the user's leg/foot |
10 |
Wear and tear, excessive stress, incorrect installation, or improper storage |
3 |
Testing and inspection of the brake lever prior to use |
3 |
90 |
Include brake lever inspection in the IFU |
| Accidental braking |
Interrupted riding; user could fall off the bike |
10 |
Improper installation, environmental interference, or accidental force application |
3 |
Fit testing before and after installation and prior to use |
1 |
30 |
Design the knee brake lever at minimum protrusion length; include a detailed installation guide |