InjuryHTW
LEVEL ONE
Received Dec 9, 2025 · Event occurred Nov 19, 2025
Report 9610905-2025-00112 · MDR key 23760863
Device
Product problems
- Fracture
- Fracture
Patient
41 YR · Female
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
H4 - DEVICE MANUFACTURE DATE, LOTS IDENTIFIED, 33683599 MFG DATE - 23-JUL-2025, 33683598 MFG DATE - 30-JUL-2025.
Additional Manufacturer Narrative
THE REPORTED RPMS EXCEEDED THE MAXIMUM RECOMMENDED SPEED FOUND IN THE IFU. LOTS IDENTIFIED 33683599, 33683598.
Description of Event or Problem
IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL FRACTURED DURING USE. A PORTION OF IT REMAINS IMPLANTED.