Hex Drill HD2.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841307119579), received between Sep 7, 2018 and Feb 20, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2023Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 16403148 ↗
• InjuryFeb 20, 2023Fracture; Fracture

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 16402673 ↗
• InjuryDec 30, 2021Osseointegration Problem; Osseointegration Problem

  PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 13116685 ↗
• MalfunctionSep 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER COMPLAINT (B)(4), "THE TIP OF THE HD2.5 DRIVER KEEP COMING OFF IMPLANT CARRIER".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125554 ↗
• MalfunctionSep 7, 2018Separation Problem; Separation Problem

  (B)(4), DURING THE OSTEOTOMY, THE IMPLANT BECAME STUCK MIDWAY. THE DOCTOR WAS UNABLE TO REMOVE THE IMPLANT WITHOUT DAMAGING THE IMPLANT OR INSTRUMENTS. THERE WAS NO ADVERSE IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7857761 ↗