inforMED
InjuryHTW

DJO SURGICAL

Received Jun 30, 2025 · Event occurred Jun 4, 2025

Report 1644408-2025-00788 · MDR key 22367409

Device

Generic name

Drill Bit, 4.0mm, Calibrated, Graduated Depth Marks

Catalog number

804-03-049

Lot number

435147L01

Product problems

  • Mechanical Problem
  • Detachment of Device or Device Component
  • Mechanical Problem
  • Detachment of Device or Device Component

Patient

NA · Female

  • Foreign Body In Patient
  • No Clinical Signs, Symptoms or Conditions
  • Foreign Body In Patient
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE

Description of Event or Problem

INSTRUMENT FAILURE - WHAT APPEARS TO BE BROKEN DRILL BIT IDENTIFIED POST SURGERY BY XRAY. THIS FRAGMENT WAS NOT CAUGHT BY SURGEON OR SURGICAL STAFF DURING PROCEDURE.