Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
FDA adverse event reports and recall history for appliance, fixation, nail/blade/plate combination, single component (product code KTW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 910
- Deaths
- 0
- Injuries
- 617
- Malfunctions
- 283
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2011-02-16TerminatedOther
02.122.550, 50mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Potential for out of specification star grind teeth.
- 2011-02-16TerminatedOther
02.122.550S, 50mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Potential for out of specification star grind teeth.
- 2011-02-16TerminatedOther
02.122.551, 50mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Potential for out of specification star grind teeth.
- 2011-02-16TerminatedOther
02.122.551S, 50mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Potential for out of specification star grind teeth.
- 2011-02-16TerminatedOther
02.122.555, 55mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Potential for out of specification star grind teeth.
- 2011-02-16TerminatedOther
02.122.556, 55mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Potential for out of specification star grind teeth.
- 2011-02-16TerminatedOther
02.122.556S, 55mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Potential for out of specification star grind teeth.
- 2011-02-16TerminatedOther
02.122.561, 60mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Potential for out of specification star grind teeth.
- 2011-02-16TerminatedOther
02.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Potential for out of specification star grind teeth.
- 2011-02-16TerminatedOther
02.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Potential for out of specification star grind teeth.
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