CORE 5400210000Recalls & reported problems
Stryker Corporation · Aria Drill · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154499991), received between Jul 23, 2019 and Jan 21, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Leak/Splash1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200286 ↗MalfunctionJan 22, 2024Fluid/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 18556870 ↗MalfunctionJan 22, 2021Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11215268 ↗MalfunctionJul 23, 2019Leak/Splash; Leak/Splash
THIS REPORT SUMMARIZES NOE 1 /NOE MALFUNCTION EVENT IN WHICH THE DEVICE WAS FOUND TO BE DAMAGED IN A MANNER THAT COULD ALLOW FOR THE ESCAPE OF GAS OR LIQUID. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 8816128 ↗
Other MOTOR, DRILL, PNEUMATIC devices
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- 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.
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