AutoMate® 663016Recalls & reported problems
Dentsply International Inc. · AutoMatrix Extra Shaft Assembly - For AutoMate III · Class 1
Quick summary
This DENTSPLY AutoMate extra shaft assembly is a dental hand instrument. The 26 reports mostly describe the shaft or instrument breaking during use, sometimes leaving pieces that were removed from patients’ mouths; there were no deaths or injuries. No recalls name this device. Reports rose from 5 in the previous 12 months to 12 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI D0026630161), received between Nov 30, 2022 and May 29, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Break” (25 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.
Reports received per month
Most reported problems
Device problems
- Break25
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATE III BROKE DURING USE. ALL BROKEN PARTS WERE REMOVED FROM PATIENT'S MOUTH. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331329 ↗MalfunctionMay 18, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATE III BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25199584 ↗MalfunctionApr 17, 2026Break
IN THIS EVENT IT WAS REPORTED THAT A AUTOMATRIX EXTRA SHAFT ASSY BROKE DURING USE. BROKEN PARTS HAVE BEEN RETRIEVED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24913377 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24859836 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24859064 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24858149 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24858069 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. ALL THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT'S MOUTH. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24858031 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. ALL THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT'S MOUTH. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857665 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. BROKEN PARTS HAVE BEEN RETRIEVED FROM PATIENT'S MOUTH. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857616 ↗MalfunctionApr 13, 2026Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24853943 ↗MalfunctionOct 30, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23422964 ↗MalfunctionJul 11, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A AUTOMATRIX TIGHTENING DEVICE BROKE DURING USE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478737 ↗MalfunctionJul 11, 2025Break; Break
IN THIS EVENT IT WAS REPORTED THAT A AUTOMATRIX TIGHTENING DEVICE BROKE DURING USE; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478391 ↗MalfunctionMar 14, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT AN AUTOMATE III BROKE DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604452 ↗MalfunctionDec 9, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX SHAFT BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20886037 ↗MalfunctionOct 18, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATE III BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20479893 ↗MalfunctionMar 15, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT AUTOMATRIX EXTRA SHAFT ASSY BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18912957 ↗MalfunctionJan 17, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT AUTOMATRIX SHAFT BROKE DURING USE. FRAGMENT RECOVERED. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18526361 ↗MalfunctionJun 28, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT AUTOMATRIX EXTRA SHAFT ASSY BROKE DURING USE IN PATIENT'S MOUTH. BROKEN PARTS WERE RETRIEVED, NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17216452 ↗MalfunctionMay 5, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT AUTOMATRIX EXTRA SHAFT ASSY BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR.
Patient problems: Insufficient Information
MAUDE report 16875979 ↗MalfunctionMay 5, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT AUTOMATRIX EXTRA SHAFT ASSY BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16875743 ↗MalfunctionMay 2, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT AUTOMATRIX EXTRA SHAFT ASSY BROKE IN PATIENT'S MOUTH DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16853982 ↗MalfunctionApr 3, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A AUTOMATRIX EXTRA SHAFT ASSEMBLY BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663064 ↗MalfunctionNov 30, 2022Break
IN THIS EVENT IT IS REPORTED THAT AUTOMATRIX EXTRA SHAFT ASSY BROKE DURING USE; CUSTOMER STATES WHEN THE EXTRA SHAFT ASSEMBLY WAS IN THE PATIENT'S MOUTH AND THE DENTIST WAS WINDING IT TIGHTER IT SNAPPED. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15885976 ↗
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- Palodent® V3 Sectional Matrix System Designed by Triodent® 659900VDentsply International Inc. · INSTRUMENTS, DENTAL HAND9 reports
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- Palodent® Plus Sectional Matrix System 659760Dentsply International Inc. · INSTRUMENTS, DENTAL HAND7 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.