Device product
3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
Z-2452-2015
Product summary
- Event
- Event 71812
- Status
- Terminated
- Classification
- Class II
- Quantity
- 121 units
- Official record key
device-enforcement:Z-2452-2015
Official wording
Reason: The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
Code information: Lot 1363-01
Distribution pattern: Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico.
Derived failure modes
-
Unknown
The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.