FDA Device Intelligence
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Thunderbolt

RESPONSIVE ORTHOPEDICS LLC · Model 285966 · UDI-DI 00811714036540

GFG Prescription
3
510(k) clearances
697
Adverse events
17
Recalls
101
Facilities

Description

Thunderbolt Button Drill

Recalls

DateFirmReason
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
2017-03-15Smith & Nephew, Inc.Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.