Device product
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
Z-0324-2016
Product summary
- Event
- Event 72529
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units distributed in the US
- Official record key
device-enforcement:Z-0324-2016
Official wording
Reason: SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
Code information: Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02
Distribution pattern: Distributed in the states of FL and TN.
Derived failure modes
-
Unknown
SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.