SKEETER® 3055601 (UDI 00681490066846)Recalls & reported problems
Medtronic Xomed, Inc. · DRILL 3055601 SKEETER OTO-TOOL ROHS · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Xomed Skeeter surgical drill is a battery-powered handpiece used in ear, nose and throat procedures. Most of the 67 reports describe the tool shaking or vibrating heavily during use, with a smaller number mentioning a broken handle or blade, overheating, or parts jamming. There are no deaths and one injury, and most reports say the patient was not affected. No recalls name this device. Reports have dropped sharply, from 25 in the earlier 12-month period to 1 in the most recent 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
- 67
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00681490066846), received between Feb 22, 2017 and Jul 28, 2026 — classified as 1 injury, 66 malfunctions.
The most frequently reported specific device problem is “Vibration” (62 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
- Vibration62
- Break3
- Mechanical Jam3
- Noise, Audible3
- Overheating of Device3
- Connection Problem2
- Mechanical Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- No Consequences Or Impact To Patient14
- Bone Fracture(s)1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50049789 ↗MalfunctionSep 8, 2025Vibration; Vibration
IT WAS REPORTED THAT INTRA OP, THE SKEETER HANDPIECE HAD TOTAL INSTABILITY OF THE INSTRUMENT TIP AT ANY ROTATION SPEED AND MICROFRAC TURE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22992344 ↗MalfunctionSep 5, 2025Break; Vibration; Break; Vibration
IT WAS REPORTED THAT THE SKEETER DRILL HAD A BROKEN HANDLE. MILLING CUTTER OR REAMER NO LONGER HOLDS AND WAS NOT STABLE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22983565 ↗MalfunctionJun 9, 2025Loose or Intermittent Connection; Vibration; Loose or Intermittent Connection; Vibration
IT WAS REPORTED THAT THE SKEETER HAD LOOSE DRILL SHEATH, EXCESSIVE VIBRATION DURING USE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22164764 ↗MalfunctionJun 5, 2025Mechanical Problem; Vibration; Mechanical Problem; Vibration
IT WAS REPORTED THAT PRIOR TO USAGE, THE SKEETER DRILL HANDPIECE WAS BROKEN. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22148503 ↗MalfunctionMay 23, 2025Vibration; Material Deformation; Vibration; Material Deformation
IT WAS REPORTED THAT PREOPERATIVELY, UNIT'S NOSE CONE WAS NOT AT DESIRED ANGLE AND WOBBLES AND BUR WOBBLES WHEN RUNNING THE UNIT. THERE WAS NO PATIENT INVOLVED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22075739 ↗MalfunctionMar 18, 2025Vibration; Noise, Audible; Vibration; Noise, Audible
IT WAS REPORTED THAT DEVICE RUNS AT 16,000 RPM BUT HAS EXCESSIVE VIBRATION AND CHATTER AT THE HEAD OF THE BUR. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21628467 ↗MalfunctionMar 17, 2025Vibration; Vibration
IT WAS REPORTED THAT THE HANDPIECE ENGINE AND BLADE WAS VIBRATING DURING USE. THERE WAS NO PATIENT IMPACT IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619609 ↗MalfunctionFeb 10, 2025Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, BURS WOBBLING IN SKEETER DRILL HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342242 ↗MalfunctionFeb 10, 2025Vibration; Vibration
IT WAS REPORTED THAT HANDPIECE BUR IS WOBBLING PRIOR TO USE. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342134 ↗MalfunctionFeb 9, 2025Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE BUR WAS WOBBLING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341297 ↗MalfunctionFeb 7, 2025Positioning Failure; Vibration; Positioning Failure; Vibration
IT WAS REPORTED THAT DURING INSTALLATION, THE BLADE WAS WOBBLING AND NOT SEATING PROPERLY IN THE SKEETER DRILL. THE BLADE WAS TURNED BEFORE USING ON THE PATIENT. THE EQUIPMENT WAS THEN CHECKED AGAIN WITH ANOTHER BURR, AND IT WAS CONFIRMED THAT THE BURR INDEED TURNS IN OVAL. THE MOTOR WAS CHANGED AUTOMATICALLY WITHOUT USING IT ON THE PATIENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21332174 ↗MalfunctionFeb 7, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, THE DEVICE HAD BUR WAS VIBRATING UNDER MICROSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21330266 ↗MalfunctionFeb 7, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, UNSTABLE BLADE/TOOL IN THE HANDPIECE, DESPITE BEING HOOKED UP WELL IT VIBRATES AND BLADE/TOOL RE PLACED BUT THE PROBLEM PERSISTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21330152 ↗MalfunctionFeb 7, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE OP THE BUR WAS OWLING IN SKEETER DRILL. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21330126 ↗MalfunctionFeb 7, 2025Vibration; Vibration
IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT SKEETER DRILL HAD BLADE WOBBLING. THERE WAS NO REPORTED PATIENT IMPACT. THE ISSUE OCCURRED PRIOR TO USE ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329981 ↗MalfunctionFeb 6, 2025Vibration; Vibration
IT WAS REPORTED THAT PRIOR TO USE, WHILE CHECKING SKEETER DRILL, BLADE WAS WOBBLING. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329874 ↗MalfunctionFeb 6, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, THE BUR WAS VIBRATING IN THE DEVICE UNDER MICROSCOPE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21321622 ↗MalfunctionFeb 6, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, THE BURR WOBBLES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21321580 ↗MalfunctionFeb 6, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PROCEDURE, THE CANULA ACCESSORY WHERE THE TOOL IS INSERTED ROTATES ABNORMALLY/BLADE WOBBLES PRIOR TO USE ON THE PATIENT. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21319167 ↗MalfunctionFeb 4, 2025Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE BUR WAS VIBRATING UNDER MICROSCOPE IN SKEETER DRILL HANDPIECE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21302707 ↗MalfunctionFeb 4, 2025Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE BUR WAS WOBBLING IN THE HANDPIECE. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21302695 ↗MalfunctionFeb 4, 2025Vibration; Vibration
IT WAS REPORTED THAT PRIOR TO USE, ONLY BUR WAS WOBBLING IN THE HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21300992 ↗MalfunctionJan 10, 2025Difficult to Insert; Vibration; Difficult to Insert; Vibration
ADDITIONAL INFORMATION RECEIVED STATING THAT THE EVENT OCCURRED INTRA-UP AND THERE WERE AT LEAST 3 BURS THAT WERE TRIED WITH THE SKEETER DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21124243 ↗MalfunctionDec 10, 2024Vibration; Vibration
IT WAS REPORTED THAT THE CUTTERS ROTATE WITH AN UNBALANCE. THE PROCEDURE WAS COMPLETED WITH OTOTOOL. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20894006 ↗
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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 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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