MalfunctionHTW
DRILL BIT QUICK COUPLING Ø2.3, L 180, HELIX 50
Received Oct 22, 2022
Report 3001406084-2021-00006 · MDR key 15656295
Device
Generic name
Bone Drill
Manufacturer
Aap Implantate AgModel number
IU 7423-18Catalog number
IU 7423-18
Lot number
I011
Product problems
- Material Separation
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IN THE COURSE OF LIQUIDATING A CONSIGNMENT STOCK, A MISSING COLOR MARKING WAS FOUND ON AN INSTRUMENT.
Additional Manufacturer Narrative
THIS IS A LATE REPORT DUE TO A CAPA CORRECTION.
Remedial action
- Replace