Device product
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0027-2013
Product summary
- Event
- Event 54725
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 Pieces
- Official record key
device-enforcement:Z-0027-2013
Official wording
Reason: The tips of the drivers are breaking while being used to drive the screws into patients.
Code information: HSC-056-38-1067061
Distribution pattern: Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.
Derived failure modes
-
Unknown
The tips of the drivers are breaking while being used to drive the screws into patients.