inforMED
InjuryELC

HU-FRIEDY

Received May 26, 2026 · Event occurred Apr 29, 2026

Report 1416605-2026-00010 · MDR key 25280165

Device

Generic name

Scaler, Ultrasonic

Model number

UI30SSXT

Catalog number

UI30SSXT

Lot number

1224

Product problems

  • Break
  • Material Fragmentation

Patient

NA · Unknown

  • Device Embedded In Tissue or Plaque

Narrative

Additional Manufacturer Narrative

ACTUAL DEVICE WAS RETURNED AND TESTED. THERE WAS NO MATERIAL HEAT TREATMENT ISSUE FOUND (51.0 HRC, 48-52 HRC SPECIFICATION). THE BACK BEND WAS FOUND TO BE WITHIN SPECIFICATION (17.27 DEG, 18 +/- 3 DEG SPECIFICATION USING KEY-001, KEYENCE VISION SYSTEM.) THERE IS NO MATERIAL HEAT TREATMENT NOR MANUFACTURING ISSUE FOUND. THE BREAKAGE MAY BE DUE TO DROPPED, BENT OR MISUSED INSERT. SINCE THE RETURN RATE IS LOW, NO FURTHER ACTIONS WERE DEEMED NECESSARY.

Description of Event or Problem

DEVICE BROKE IN PATIENT'S MOUTH. A FLAP IN THE GUMS WAS MADE TO GET THE PIECE OUT.