Device product
Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.
Z-2236-2021
Product summary
- Firm
- NEOSTEO
- Event
- Event 88307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-2236-2021
Official wording
Reason: Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially leading to the following risks: Inflammation, pain, allergy, adverse tissue reaction. Device description: The drill bit is used to create the hole required for the introduction of the screw, it is suitable for Neosteo compression screws for cortical and spongy bone. Drilling depth can be read on the instrument. The shaft is coupled with the ¿4.5mm surgical motor using a AO ¿4.5mm male drive connexion. The countersink bit is coupled to a ¿1.0mm k-wire to ensure guiding while drilling. The instrument is packaged in a plastic sheath sealed by welding.
Code information: Lot: 243-20
Distribution pattern: US Nationwide distribution in the state of New Jersey.
Derived failure modes
-
Unknown
Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially leading to the following risks: Inflammation, pain, allergy, adverse tissue reaction. Device description: The drill bit is used to create the hole required for the introduction of the screw, it is suitable for Neosteo compression screws for cortical and spongy bone. Drilling depth can be read on the instrument. The shaft is coupled with the ¿4.5mm surgical motor using a AO ¿4.5mm male drive connexion. The countersink bit is coupled to a ¿1.0mm k-wire to ensure guiding while drilling. The instrument is packaged in a plastic sheath sealed by welding.