MalfunctionHTW
MILLENNIUM
Received Aug 14, 2019
Report 1421101-2019-00002 · MDR key 8892901
Device
Generic name
Cement Removal Drill Bits Wide 11"
Manufacturer
Millennium SurgicalModel number
1-CR14Catalog number
1-CR14
Lot number
374003
Product problems
- Break
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
CUSTOMER COMPLAINED THAT 1EA OF 1-CR14, A CEMENT DRILL BIT, BROKE DURING A PROCEDURE AND EXTRA STEPS WERE TAKEN TO RETRIEVE IT FROM THE PATIENT BEING OPERATED ON.