RemB 6400015000Recalls & reported problems
Stryker Corporation · Electric Micro Drill · Class 2
Quick summary
This Stryker RemB electric micro drill is a surgical drill used in ear, nose and throat surgery. Of the 603 reports naming it, most describe the drill overheating, and many describe it remaining switched on or parts detaching. The reports include 1 injury and no deaths, and reports fell from 17 in the previous 12 months to 1 in the latest 12 months. 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
- 603
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 603 adverse event reports that list this exact device (DI 07613154938254), received between Jul 24, 2018 and Dec 23, 2025 — classified as 1 injury, 602 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (386 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
- Overheating of Device386
- Device Remains Activated109
- Detachment of Device or Device Component71
- Fluid/Blood Leak20
- Unintended Power Up13
- Component Missing7
- Fracture3
- Fail-Safe Did Not Operate2
Patient problems
- No Clinical Signs, Symptoms or Conditions363
- No Patient Involvement183
- No Consequences Or Impact To Patient43
- Burn(s)20
- No Known Impact Or Consequence To Patient13
- Insufficient Information8
- No Information5
- Partial thickness (Second Degree) Burn3
Recent adverse event reports
The 25 most recent of 603 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Overheating of Device; Overheating of Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878381 ↗MalfunctionOct 22, 2025Overheating of Device; Overheating of Device
IT WAS 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 23360792 ↗MalfunctionOct 17, 2025Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES & THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23322642 ↗MalfunctionSep 4, 2025Overheating of Device; Overheating of Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963062 ↗MalfunctionSep 4, 2025Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT, NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, THERE WAS CLINICALLY INSIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962878 ↗MalfunctionAug 20, 2025Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850814 ↗MalfunctionJun 5, 2025Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT.
Patient problems: Insufficient Information
MAUDE report 22149339 ↗MalfunctionFeb 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A MANUFACTURER FIELD SERVICE REPRESENTATIVE REPORTED THAT THE DEVICE WAS MISSING A COMPONENT DURING A DEMO VISIT 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 21445665 ↗MalfunctionFeb 3, 2025Overheating of Device; Overheating of Device
THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES & THE PROCEDURE WAS COMPLETED SUCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21291358 ↗MalfunctionJan 9, 2025Overheating of Device; Overheating of Device
PER THE SALES REPRESENTATIVE, THE DEVICE IS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21114501 ↗MalfunctionJan 9, 2025Overheating of Device; Overheating of Device
PER THE SALES REPRESENTATIVE, THE DEVICE IS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113724 ↗MalfunctionJan 9, 2025Overheating of Device; Overheating of Device
PER THE SALES REPRESENTATIVE, THE DEVICE IS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113713 ↗MalfunctionJan 9, 2025Overheating of Device; Overheating of Device
PER THE SALES REPRESENTATIVE, THE DEVICE IS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113589 ↗MalfunctionJan 9, 2025Overheating of Device; Overheating of Device
PER THE SALES REPRESENTATIVE, THE DEVICE IS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113555 ↗MalfunctionJan 9, 2025Overheating of Device; Overheating of Device
PER THE SALES REPRESENTATIVE, THE DEVICE IS OVERHEATING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113439 ↗MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
PER THE SERVICE TECHNICIAN, THE DEVICE WAS MISSING A COMPONENT DURING TESTING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21106516 ↗MalfunctionNov 14, 2024Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT THE DEVICE WAS SLOW BRAKING 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 20685717 ↗MalfunctionNov 7, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING A CASE AT THE USER FACILITY AND A PATIENT RECEIVED BURNS TO THEIR MOUTH. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Patient problems: Burn(s)
MAUDE report 20632852 ↗MalfunctionOct 28, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE WAS HOT 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 20547205 ↗MalfunctionOct 22, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING A DEMO VISIT 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 20510738 ↗MalfunctionOct 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE WAS MISSING A COMPONENT DURING DEMO VISIT 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 20396464 ↗MalfunctionSep 19, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE WAS HOT 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 20263176 ↗MalfunctionSep 16, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE BURNED A PATIENT DURING A PROCEDURE AT THE USER FACILITY. MULTIPLE ATTEMPTS WERE MADE TO GATHER MORE INFORMATION; HOWEVER, THE USER FACILITY DID NOT PROVIDE ANY FURTHER DETAILS.
Patient problems: Burn(s)
MAUDE report 20232234 ↗MalfunctionSep 16, 2024Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT THE DEVICE WAS SLOW BRAKING DURING A DEMO VISIT 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 20231939 ↗MalfunctionSep 11, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE DEVICE WAS HEATING UP 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 20193887 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.