inforMED
MalfunctionHTW

AFFINITI GLENOID STARTER/PERIPHERAL DRILL BIT

Received Sep 12, 2014 · Event occurred Sep 2, 2014

Report 3004983210-2014-00020 · MDR key 4107474

Device

Generic name

None

Manufacturer

Tornier Inc.

Catalog number

9000255

Product problems

  • Break

Patient

Not reported

  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

THE DRILL BIT SNAPPED IN TWO WHEN SURGEON USED IT. A PORTION OF THE DRILL BIT REMAINS IN THE PATIENT.

Additional Manufacturer Narrative

THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.