SKEETER® 3055601 (UDI 00643169882676)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 drill is a small surgical handpiece used in ear, nose and throat procedures. The 30 reports describe a vibrating or wobbling handpiece — most often the drill bit or burr shaking in the holder — and most were found during pre-op checks or servicing, with no patient involved. No deaths and no injuries were reported, and 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00643169882676), received between Oct 28, 2020 and Jun 23, 2025 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Vibration” (26 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
- Vibration26
- Noise, Audible3
- Break1
- Connection Problem1
- Device Remains Activated1
- Failure to Align1
- Material Twisted/Bent1
- Overheating of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2025Vibration; Vibration
IT WAS REPORTED THAT THE DEVICE RETURNED FOR PLANNED MAINTENANCE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22304910 ↗MalfunctionJun 23, 2025Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE SKEETER DRILL HANDPIECE WAS NOT WORKING. THERE WAS NO PATIENT IMPACT. SERVICE AND REPAIR TEAM FOUND THAT THE SKEETER DRILL WAS VIBRATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22304865 ↗MalfunctionFeb 10, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, BUR WAS NOT STABLE AND VIBRATING IN SKEETER DRILL. THE BUR WAS WORKING FINE WITH ANOTHER HANDPIECE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343232 ↗MalfunctionFeb 7, 2025Vibration; Connection Problem; Material Twisted/Bent; Vibration; Connection Problem; Material Twisted/Bent
IT WAS REPORTED THAT DURING SETUP, THE SHAFT OF THE SKEETER DRILL IS BENT AND DRILL BIT IS NOT SITTING PROPERLY, IT IS WOBBLY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21332686 ↗MalfunctionFeb 7, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING USE, THE SKEETER DRILL METAL TIP WHICH HOLDS THE BUR WAS TOO SHORT AND THE BUR WOBBLES. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21331561 ↗MalfunctionFeb 7, 2025Vibration; Vibration
IT WAS REPORTED THAT DURING PRE-OP, IN SKEETER DRILL THE TIP OF THE BUR VIBRATES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21331049 ↗MalfunctionFeb 7, 2025Vibration; Vibration
IT IS REPORTED BY HEALTH CARE PROFESSIONAL THAT THE BLADE WAS WOBBLING IN THE SKEETER HANDPIECE. THE VIBRATION WAS FOUND PRIOR TO USE ON PATIENT AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21329978 ↗MalfunctionFeb 6, 2025Vibration; Vibration
IT WAS REPORTED THAT PRE-OP, THE BUR WOBBLES IN SKEETER HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21320283 ↗MalfunctionFeb 4, 2025Vibration; Noise, Audible; Vibration; Noise, Audible
IT WAS REPORTED THAT PRE-OP, THE SKEETER DRILL HANDPIECE WAS GETTING NOISY AND THE BUR WAS WOBBLING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21301205 ↗MalfunctionNov 29, 2024Vibration; Vibration
IT WAS REPORTED THAT DEVICE WAS RETURNED FOR PLANNED MAINTENANCE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20808474 ↗MalfunctionOct 28, 2024Vibration; Noise, Audible; Vibration; Noise, Audible
IT WAS REPORTED THAT PRE-OP, THE SKEETER DRILL HAD BUR WOBBLING AND WAS MAKING NOISE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20546388 ↗MalfunctionJul 16, 2024Vibration; Vibration
IT WAS REPORTED THAT THE SKEETER DRILL AND BURS WERE VIBRATING, NOT PRECISE ENOUGH FOR MICROSURGERY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19747954 ↗MalfunctionApr 19, 2024Vibration; Vibration
IT WAS REPORTED THAT DURING INTRA OP THE BUR WOBBLING IN SKEETER HANDPIECE. MULTIPLE BURS WERE USED WITH THIS HANDPIECE AND SAME ISSUE OCCURRED. THE VIBRATING DEVICE USED ON PATIENT AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19141788 ↗MalfunctionApr 2, 2024Vibration; Vibration
IT WAS REPORTED THAT SKEETER DRILL WAS NOT WORKING. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION STATE'S THAT DEVICE WAS WOBBLING. VIBRATING DEVICE NOT USED ON THE PATIENT. DEVICE CHECKED FOR VIBRATION/WOBBLE PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19021815 ↗MalfunctionMar 8, 2024Vibration; Noise, Audible; Vibration; Noise, Audible
IT WAS REPORTED THAT POST-OP CABLE WAS ACCIDENTLY CUT. NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18863783 ↗MalfunctionFeb 27, 2024Vibration; Failure to Align; Vibration; Failure to Align
IT WAS REPORTED THAT RE-OP, THE DRILL DOES NOT CENTER PROPERLY, THERE SEEMS TO BE PLAY ON IT. THERE ARE ALSO OFTEN PROBLEMS WITH LOCKING. CHECKED WHETHER THE BUR WAS ALIGNED STRAIGHT, WHEN THE BUR WAS PLACED IN THE SKEETER HANDPIECE, IT WAS DIFFICULT TO GET THE MARKING ON THE BUR INTO THE HANDPIECE PROPERLY AND IT WAS DIFFICULT TO PRESS THE BUTTON PROPERLY TO LOCK THE DRILL IN THE HANDPIECE, THAT WAS VERY STIFF. WHEN THE BUR WAS PLACED CORRECTLY IN THE SKEETER HANDPIECE, THE BUR WAS DRILLING CONCENTRICALLY. THIS RESULTS IN A LARGER HOLE BEING DRILLED THAN NECESSARY. IT LOOKED LIKE THERE WAS SOMETHING WRONG WITH THE CONNECTION BETWEEN THE SKEETER HANDPIECE AND THE BUR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18786822 ↗MalfunctionOct 27, 2023Vibration; Vibration
IT WAS REPORTED THAT THE DRILL IS VIBRATING BECAUSE THE BUR CLIP SYSTEM IS NOT WORKING. THE BUR IS NOT WELL FIXED TO THE DRILL. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18018360 ↗MalfunctionJun 13, 2023Vibration; Vibration
IT WAS REPORTED THAT SKEETER DRILL VIBRATES DURING USE. THE DEVICE WAS CHECKED THE CORRECT FUNCTIONING PRIOR TO USE AND THE DRILL HAS STARTED TO VIBRATE WHEN IN CONTACT WITH THE PATIENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17120057 ↗MalfunctionJun 6, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT PRIOR TO PROCEDURE SKEETER DRILL OVERHEATS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17073471 ↗MalfunctionMay 2, 2023Vibration; Vibration
IT REPORTED THAT THE DEVICE RETURNED WITHOUT ANY COMMENTS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16851309 ↗MalfunctionApr 19, 2023Vibration; Vibration
IT WAS REPORTED THAT DURING INTRA OP SKEETER DRILL WAS SHAKING, CONSIDERABLE EXTRA VIBRATION TO MOVEMENT. THE DEVICE WAS USED ON PATIENT AND THE DEVICE WAS NOT CHECKED FOR VIBRATION PRIOR TO USE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16767145 ↗MalfunctionApr 17, 2023Vibration; Vibration
IT WAS REPORTED THAT DURING OPERATION SKEETER DRILL STARTING AND STOPPING AND JUMPING. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED, VIBRATING DEVICE WAS USED ON THE PATIENT. THE SURGEON STATED THE HANDPIECE THAT WAS CAUSING THE UNWANTED VIBRATION. THE ATTACHMENT/DISPOSABLE WAS CHECKED BY THE SURGEON THAT IT WAS ATTACHED PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16756070 ↗MalfunctionMar 6, 2023Device Remains Activated; Device Remains Activated
AFTER OPERATION DEVICE ACTIVATED IMMEDIATELY WHEN PLUGGED INTO POWER SOURCE AND WHEN THE USER TRIED TO DISCONTINUE TO USE THE ATTACHMENT KEPT RUNNING. THE DEVICE DID NOT TURN ON BY ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16492245 ↗MalfunctionMar 1, 2023Self-Activation or Keying; Self-Activation or Keying
IT WAS REPORTED DURING INTRA-OP THAT THE DEVICE HAD LACK OF ENERGY IN THE MILLING MACHINE. TURNS ON ALONE. THERE WAS NO PATIENT INVOLVED. THERE WAS NO USER COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16457756 ↗MalfunctionJan 16, 2023Vibration; Vibration
IT WAS REPORTED BY HCP THAT DURING OP SKEETER DRILL TIP WAS NOT STABLE WHEN DRILLING. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16172650 ↗
Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices
- RemB 6400034000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,618 reports
- NA XMAXAnspach Effort, The · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1,225 reports
- NA EG1ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE859 reports
- NA CRANI-ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall772 reports
- NA 5450400000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE775 reports
- NA 05.001.010Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE770 reports
- RemB 6400015000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE603 reports
- NA QD11Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE580 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