InjuryHTW
LEVEL ONE
Received Jun 24, 2026 · Event occurred Jun 8, 2026
Report 1000525271-2026-00031 · MDR key 25610331
Device
Product problems
- Fracture
Patient
38 YR · Female
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THE REPORTED RPMS EXCEEDED THE MAXIMUM RECOMMENDED SPEED FOUND IN THE IFU.
Description of Event or Problem
IT WAS REPORTED DURING INITIAL SURGERY THAT A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.