Maestro 5400210020Recalls & reported problems
Stryker Corporation · PD Series Straight "O" Attachment · Class 2
All models of Maestro (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker PD Series straight "O" attachment is a surgical drill attachment used with powered handpieces. All 27 reports describe the attachment overheating, mostly during testing or servicing at the user facility rather than during a procedure. None mention patient involvement, injuries or deaths. No recalls name this device.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04546540469168), received between Jul 24, 2018 and Feb 6, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (27 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device27
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Patient Involvement2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24278710 ↗MalfunctionNov 11, 2025Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522375 ↗MalfunctionNov 11, 2025Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522374 ↗MalfunctionNov 11, 2025Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522372 ↗MalfunctionNov 11, 2025Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522371 ↗MalfunctionNov 11, 2025Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522368 ↗MalfunctionJul 22, 2025Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563937 ↗MalfunctionJul 22, 2025Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563936 ↗MalfunctionAug 7, 2024Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE THEY WERE CONDUCTING A DEMONSTRATION AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19934174 ↗MalfunctionJul 26, 2024Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE THEY WERE CONDUCTING A DEMONSTRATION AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19841433 ↗MalfunctionJun 1, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17039496 ↗MalfunctionMay 25, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17001265 ↗MalfunctionMay 25, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17001264 ↗MalfunctionMay 25, 2023Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17001203 ↗MalfunctionFeb 8, 2022Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13483270 ↗MalfunctionJul 1, 2021Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12099740 ↗MalfunctionJul 1, 2021Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12099730 ↗MalfunctionMay 27, 2021Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11893565 ↗MalfunctionMay 21, 2021Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11865495 ↗MalfunctionMay 21, 2021Overheating of Device; Overheating of Device
THE MANUFACTURER FIELD SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING DEMONSTRATED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11865482 ↗MalfunctionMar 19, 2021Overheating of Device; Overheating of Device
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED. THE EVENT OCCURRED DURING FUNCTIONAL TESTING WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11526725 ↗MalfunctionFeb 12, 2021Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING TESTING PRIOR TO A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11322350 ↗MalfunctionNov 20, 2020Overheating of Device; Overheating of Device
THE MANUFACTURER SALES REPRESENTATIVE REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE AT THE USER FACILITY. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10876343 ↗MalfunctionNov 10, 2020Overheating of Device; Overheating of Device
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED. THE EVENT OCCURRED DURING FUNCTIONAL TESTING WHILE IT WAS BEING SERVICED AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10820002 ↗MalfunctionFeb 20, 2019Overheating of Device; Overheating of Device
THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 8355423 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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