inforMED
MalfunctionHTW

PROVISION

Received Jun 9, 2025 · Event occurred May 22, 2025

Report 22166379 · MDR key 22166379

Device

Generic name

Bit, Drill

Manufacturer

Medartis Inc

Model number

A-3230

Product problems

  • Break
  • Difficult to Remove

Patient

34 YR · Female

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

PATIENT WENT TO THE OPERATING ROOM FOR A ORIF [OPEN REDUCTION AND INTERNAL FIXATION], RIGHT METACARPAL FRACTURE. MEDARTIS KIT WAS USED FOR IMPLANTS. DURING THE PROCEDURE FOUR DIFFERENT DRILL BITS BROKE AND BECAME STUCK INSIDE THE PATIENT. SURGEON WAS ABLE TO REMOVE TWO OF THEM, HOWEVER TWO PIECES OF DRILL BIT REMAINED IN THE BONE.