MalfunctionHTW
DRILL BIT QUICK COUPLING Ø3.8, L 200, HELIX 50
Received Dec 2, 2022 · Event occurred Nov 2, 2022
Report 3001406084-2022-00006 · MDR key 15903641
Device
Generic name
Bone Drill
Manufacturer
Aap Implantate AgModel number
IU 7438-22Catalog number
IU 7438-22
Lot number
I003
Product problems
- Material Separation
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BOTH MECHANICAL AND CHEMICAL STRESSES CAN BE CONSIDERED AS CAUSES FOR THE DAMAGE OF THE COLOR RINGS. IN ADDITION, A REDUCTION IN MECHANICAL AND CHEMICAL RESISTANCE DUE TO MATERIAL AGING CAN BE ASSUMED.
Description of Event or Problem
IN THE COURSE OF LIQUIDATING A CONSIGNMENT STOCK, A MISSING COLOR MARKING WAS FOUND ON AN INSTRUMENT.
Remedial action
- Replace