Device product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Z-1847-2017
Product summary
- Event
- Event 76824
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1847-2017
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: F91770, F92141, G10378, G10379, G10788, G10790 G11229, G11230, G11235, G11236, G15938, G15939, G18830, G18832 G27835, G27835, G27836, G30217, G30218, G30250, G30251, G32170
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