NA 201-78-89Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862045621), received between Jan 26, 2021 and Jan 26, 2021 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE DRILL BIT BENT DURING INSERTION THROUGH THE PROXIMAL TIBIAL CUT GUIDE. THE GUIDE DIRECTS THE PIN TOWARD THE MEDIAL CORTEX OF THE TIBIA AND THE BONE IS EXTREMELY HARD WHICH MOST LIKELY CAUSE THE PIN TO BEND AND CAUSE A CORTICOTOMY. THE PATIENT WAS DISCHARGED AS PLANNED.. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS MIXED IN WITH THE OTHER DRILLS USED DURING THE SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11229249 ↗