Device product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Z-1844-2017
Product summary
- Event
- Event 76824
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1844-2017
Official wording
Reason: Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Code information: Batch Numbers: F93301, F93303, G04665, G27840, G27841
Distribution pattern: Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
Derived failure modes
-
Unknown
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming