SKEETER 3055601Recalls & reported problems
Medtronic Xomed, Inc. · DRILL 3055601 SKEETER OTO-TOOL ROHS · Class 2
All models of SKEETER (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00763000378004), received between Dec 27, 2023 and Sep 9, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Vibration” (19 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Vibration19
- Device Remains Activated3
- Noise, Audible2
- Mechanical Jam1
- Physical Resistance/Sticking1
- Self-Activation or Keying1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Vibration
It was reported that intra-op, the bur wobbles in the skeeter drill. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50686757 ↗MalfunctionSep 9, 2026Vibration
It was reported that during use the blade wobbles, have an oscillation during rotation. The user informs that several blades of various batches have been tried and the problem remains. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50684091 ↗MalfunctionSep 1, 2026Vibration
It was reported that pre op bur is wobbling in skeeter. There was no patient involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50536812 ↗MalfunctionAug 12, 2025Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, IT WAS FOUND THAT THE SKEETER DRILL BUR IS WOBBLING UNDER MICROSCOPE EVEN AFTER REPLACING THE BUR WITH NEW ONE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22789695 ↗MalfunctionJun 24, 2025Vibration; Vibration
IT WAS REPORTED DURING PRE-OP, THE NEW SKEETER DRILL'S BUR EXHIBITED WOBBLING AT 400-500 RPM DURING THE FIRST-TIME USE. THERE WAS NO DAMAGE NOTICED ON SKEETER DRILL OR ITS PACKAGE. USER DID NOT CHECK BUR WITH OTHER SKEETER DUE TO UNAVAILABILITY OF OTHER SKEETER DRILL TO CHECK. USER TESTED OTHER BUR IN THIS SKEETER AND IT WOBBLED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22313475 ↗MalfunctionApr 28, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, THE BUR WOBBLING IN SKEETER HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21916578 ↗MalfunctionFeb 25, 2025Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT PRIOR TO PROCEDURE IN SKEETER DRILL FRONT PIECE OF THE DRILL KEEPS ROTATING AND IT DID NOT FUNCTION. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21455296 ↗MalfunctionFeb 10, 2025Vibration; Vibration
IT WAS REPORTED DURING PRE-OP, WHILE INSTALLATION, BUR IS WOBBLING. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21342096 ↗MalfunctionFeb 10, 2025Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, BUR WAS WOBBLING. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341920 ↗MalfunctionFeb 10, 2025Vibration; Vibration
IT WAS REPORTED THAT, DURING PRE-OP THERE WAS A BUR WOBBLE ISSUE IN SKEETER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341697 ↗MalfunctionDec 31, 2024Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT THE TIP TURNS ON ITSELF WHEN IT SHOULDN'T. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047894 ↗MalfunctionDec 31, 2024Vibration; Vibration
IT WAS REPORTED THAT DEVICE HAD EXCESSIVE VIBRATION. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047867 ↗MalfunctionDec 10, 2024Vibration; Noise, Audible; Vibration; Noise, Audible
IT WAS REPORTED THAT THE SKEETER DRILL IS UNBALANCED AND MAKES A LOT OF NOISE, AND INDICATES AN ERROR PRIOR TO USE AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20890592 ↗MalfunctionDec 8, 2024Vibration; Vibration
IT WAS REPORTED THAT INTRA OP, DRILL WAS PRODUCING A 1MM HOLE WHEN EXPECTED TO ONLY BE 0.6MM DUE TO WOBBLING. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20874461 ↗MalfunctionSep 9, 2024Vibration; Mechanical Jam; Noise, Audible; Physical Resistance/Sticking; Vibration; Mechanical Jam; Noise, Audible; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING INTRA-OP, THE DISPOSABLE BURR NOT CLICKING INTO PLACE, THE BURR CLICKING THE PLACE IN BUT CREATING TOO MUCH CHATTER/EXCESSIVE MOTION, TO NOT TURNING ON AT ALL. THERE WAS 6 HOUR DELAY IN THE PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20166578 ↗MalfunctionSep 2, 2024Vibration; Vibration
IT WAS REPORTED THAT DURING THE PRE-OP INSPECTION, FOUND THAT THE BUR WAS WOBBLING. THERE IS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20115999 ↗MalfunctionJul 7, 2024Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE SKEETER DRILL HP WAS WOBBLING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19686389 ↗MalfunctionJun 4, 2024Self-Activation or Keying; Self-Activation or Keying
IT WAS REPORTED THAT IN SKEETER DRILL TIP WAS SPINNING WHEN THE DRILL WAS ON. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19456608 ↗MalfunctionMay 27, 2024Device Remains Activated; Device Remains Activated
IT WAS REPORTED THAT PRIOR TO USE, TIP SPINNING WHEN DRILL IS ACTIVATED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19399747 ↗MalfunctionApr 26, 2024Vibration; Vibration
IT WAS REPORTED THAT PRIOR TO USE, THE BUR WOBBLES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19191751 ↗MalfunctionApr 23, 2024Vibration; Vibration
ADDITIONAL INFORMATION RECEIVED STATING THAT THE BURRS WERE NOT TESTED WITH ANY OTHER SKEETER SINCE CUSTOMER DIDN'T HAVE ANY OTHER SKEETER TO TEST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19161970 ↗MalfunctionFeb 12, 2024Vibration; Vibration
IT WAS REPORTED THAT DRILL BIT WAS WOBBLING PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18686632 ↗MalfunctionDec 27, 2023Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, THE SKEETER HANDPIECE END WAS MOVING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18401307 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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