CORE, Maestro 5400201000Recalls & reported problems
Stryker Corporation · Drill with Handswitch · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker pneumatic drill with a handswitch is used in surgery. The 45 reports describe the drill starting on its own without anyone pressing the controls, parts coming loose and detaching, safety features not working, and fluid or blood leaking out. No deaths and no injuries were reported, and most events happened during non-clinical testing with no patient involved. 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
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 04546540503947), received between Jul 24, 2018 and Jul 29, 2025 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Unintended Power Up” (12 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
- Unintended Power Up12
- Detachment of Device or Device Component11
- Fail-Safe Problem7
- Fluid/Blood Leak5
- Leak/Splash5
- Fail-Safe Did Not Operate2
- Overheating of Device2
- Device Remains Activated1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Patient Involvement14
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FAIL-SAFE DID NOT OPERATE. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22646519 ↗MalfunctionApr 21, 2025Fail-Safe Problem; Fail-Safe Problem
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. - 2 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876261 ↗MalfunctionApr 16, 2024Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES (B)(4) MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - (B)(4) EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19113446 ↗MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18556851 ↗MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16807802 ↗MalfunctionApr 24, 2023Unintended Power Up; Unintended Power Up
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16802855 ↗MalfunctionApr 24, 2023Device Remains Activated; Device Remains Activated
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD RUN-ON. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16801793 ↗MalfunctionJan 29, 2023Unintended Power Up; Unintended Power Up
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16261775 ↗MalfunctionOct 25, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15667827 ↗MalfunctionOct 24, 2022Unintended Power Up; Unintended Power Up
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15663710 ↗MalfunctionJul 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15102049 ↗MalfunctionApr 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14193227 ↗MalfunctionApr 25, 2022Unintended Power Up; Unintended Power Up
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14193225 ↗MalfunctionApr 25, 2022Fail-Safe Problem; Fail-Safe Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14193220 ↗MalfunctionJan 19, 2022Unintended Power Up; Fluid/Blood Leak; Unintended Power Up; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING AND RAN WITHOUT USER ACTIVATION. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13290101 ↗MalfunctionOct 22, 2021Unintended Power Up; Unintended Power Up
THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12679872 ↗MalfunctionJul 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12203322 ↗MalfunctionJul 21, 2021Unintended Power Up; Unintended Power Up
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12203313 ↗MalfunctionApr 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11728625 ↗MalfunctionApr 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11728524 ↗MalfunctionJan 22, 2021Unintended Power Up; Unintended Power Up
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11215335 ↗MalfunctionJan 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11215235 ↗MalfunctionOct 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10748573 ↗MalfunctionJul 27, 2020Unintended Power Up; Unintended Power Up
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE RAN WITHOUT USER ACTIVATION. - 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10330231 ↗MalfunctionApr 29, 2020Fail-Safe Problem; Fail-Safe Problem
THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE EXPERIENCED A FAIL-SAFE PROBLEM THAT COULD RESULT IN UNINTENDED ACTIVATION. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 10008377 ↗
Other MOTOR, DRILL, PNEUMATIC devices
- NA 05.001.080Synthes GmbH · MOTOR, DRILL, PNEUMATIC432 reports
- NA CSR60Synthes GmbH · MOTOR, DRILL, PNEUMATIC221 reports
- Midas Rex® AF02Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC163 reports
- Maestro Air 5407-200-000Stryker Corporation · MOTOR, DRILL, PNEUMATIC112 reports
- Maestro 5400210060Stryker Corporation · MOTOR, DRILL, PNEUMATIC95 reports
- MIDAS REX™ AF02Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC91 reports
- CORE, Maestro 5400200000Stryker Corporation · MOTOR, DRILL, PNEUMATIC75 reports
- Maestro Air 5407-200-00HStryker Corporation · MOTOR, DRILL, PNEUMATIC56 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page