N/A 3155637Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00681490070492), received between Oct 28, 2020 and Jan 30, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Vibration” (14 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRE-OP, THE BURS WERE WOBBLING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271015 ↗
• MalfunctionJan 30, 2025Vibration; Vibration

  IT WAS REPORTED THAT, DURING SERVICING SKEETER DRILL AND BURS WERE WOBBLING. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270838 ↗
• MalfunctionNov 6, 2020Vibration; Vibration

  ON FOLLOW-UP IT WAS REPORTED THAT THE BUR WAS SEATED CORRECTLY. IT WAS VERIFIED BY THE SALES REPRESENTATIVE SEVERAL TIMES, AND THE SURGEON HAS BEEN USING THIS TYPE OF DRILL FOR OVER 15 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10805436 ↗
• InjuryNov 5, 2020Vibration; Vibration

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT ALL OF THE DRILLS AND BURS USED BY THE DOCTOR DURING THE STAPEDECTOMY, THE DEVICE WOBBLED INSTEAD OF ROTATING IN A STABLE FASHION. INSTEAD OF THE BUR CREATING A SMALL OPENING IN THE INCUS, A FRACTURE WAS CREATED INSTEAD. THIS HAPPENED LAST WEEK WITH A DIFFERENT PATIENT. HOWEVER, THIS TIME,THE DOCTOR WAS NOT CERTAIN THAT ALL OF THE FRAGMENT OUT IN ITS ENTIRETY. UPON FOLLOW UP IT WAS CONFIRMED THAT NO BUR FRAGMENT WAS SUSPECTED TO BE LEFT BEHIND, AS THE BUR DID NOT BREAK.

  Patient problems: Bone Fracture(s)

  MAUDE report 10790098 ↗
• InjuryNov 4, 2020Vibration; Vibration

  A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE EVENT DURING STAPEDECTOMY CAUSED A FRACTURE IN INCUS INSTEAD OF A CONTROLLED DRILLING. TWO BURS WERE USED IN THE CASE AND BOTH WOBBLED. THE BURS DID NOT ROTATE PROPERLY - THE TIP OSCILLATES OR 'WOBBLES'. THE FRAGMENT WAS RECOVERED SO THERE WAS NO LONG-LASTING HARM TO THE PATIENT HOWEVER, THE PROCEDURE DID NOT GO AS PLANNED. THERE WAS 20 MINUTES DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10786331 ↗
• InjuryNov 4, 2020Vibration; Vibration

  A HEALTH CARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE EVENT DURING STAPEDECTOMY CAUSED A FRACTURE IN INCUS INSTEAD OF A CONTROLLED DRILLING. TWO BURS WERE USED IN THE CASE AND BOTH WOBBLED. THE BURS DID NOT ROTATE PROPERLY - THE TIP OSCILLATES OR 'WOBBLES'. THE FRAGMENT WAS RECOVERED SO THERE WAS NO LONG-LASTING HARM TO THE PATIENT HOWEVER, THE PROCEDURE DID NOT GO AS PLANNED. THERE WAS 20 MINUTES DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 10786279 ↗
• MalfunctionNov 3, 2020Vibration; Vibration

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT THE DRILL AND BUR USED BY THE DOCTOR DURING THE STAPEDECTOMY WOBBLED INSTEAD OF ROTATING IN A STABLE FASHION. THERE WAS NO PATIENT IMPACT ALTHOUGH THE BUR WAS IN CONTACT WITH PATIENT. THE DEVICES WERE STILL USED AND ABLE TO FINISH THE PROCEDURE. THERE WERE APPROXIMATELY 5 MINUTES DELAY IN THE 45 MINUTES PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10779707 ↗
• MalfunctionNov 3, 2020Vibration; Vibration

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT THE DRILL AND BUR USED BY THE DOCTOR DURING THE STAPEDECTOMY WOBBLED INSTEAD OF ROTATING IN A STABLE FASHION. THERE WAS NO PATIENT IMPACT ALTHOUGH THE BUR WAS IN CONTACT WITH PATIENT. THE DEVICES WERE STILL USED AND ABLE TO FINISH THE PROCEDURE. THERE WERE APPROXIMATELY 5 MINUTES DELAY IN THE 45 MINUTES PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10779587 ↗
• MalfunctionNov 3, 2020Vibration; Vibration

  ON FOLLOW-UP IT WAS REPORTED THAT THE BUR WAS SEATED CORRECTLY. IT WAS VERIFIED BY THE SALES REPRESENTATIVE SEVERAL TIMES, AND THE SURGEON HAS BEEN USING THIS TYPE OF DRILL FOR OVER 15 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10779353 ↗
• MalfunctionOct 28, 2020Vibration; Vibration

  ON FOLLOW-UP IT WAS REPORTED THAT THE BUR WAS SEATED CORRECTLY. IT WAS VERIFIED BY THE SALES REPRESENTATIVE SEVERAL TIMES, AND THE SURGEON HAS BEEN USING THIS TYPE OF DRILL FOR OVER 15 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10748853 ↗
• MalfunctionOct 28, 2020Vibration; Vibration

  ON FOLLOW-UP IT WAS REPORTED THAT THE BUR WAS SEATED CORRECTLY. IT WAS VERIFIED BY THE SALES REPRESENTATIVE SEVERAL TIMES, AND THE SURGEON HAS BEEN USING THIS TYPE OF DRILL FOR OVER 15 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10748782 ↗
• MalfunctionOct 28, 2020Vibration; Vibration

  EACH OF THE REPORTED BURS THAT WOBBLED WERE INITIAL USE, NOT REPROCESSED, AND SOME WOBBLED RIGHT OUT OF THE PACKAGE. TO TROUBLESHOOT THE ISSUE, THE DOCTOR TRIED USING THE BURS IN DIFFERENT HANDPIECES, TO SEE THE RESULT. EACH OF THE BURS WOBBLED IN A SECOND HANDPIECE; HOWEVER, IT WAS FOUND THAT THERE WAS VARIABILITY ON HOW MUCH OF A WOBBLE WAS EVIDENT WITH EACH HANDPIECE (EITHER MORE WOBBLE, OR LESS). THE FACILITY DETERMINED THAT THIS WAS AN ISSUE WITH THEIR HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10748702 ↗
• MalfunctionOct 28, 2020Vibration; Vibration

  EACH OF THE REPORTED BURS THAT WOBBLED WERE INITIAL USE, NOT REPROCESSED, AND SOME WOBBLED RIGHT OUT OF THE PACKAGE. TO TROUBLESHOOT THE ISSUE, THE DOCTOR TRIED USING THE BURS IN DIFFERENT HANDPIECES, TO SEE THE RESULT. EACH OF THE BURS WOBBLED IN A SECOND HANDPIECE; HOWEVER, IT WAS FOUND THAT THERE WAS VARIABILITY ON HOW MUCH OF A WOBBLE WAS EVIDENT WITH EACH HANDPIECE (EITHER MORE WOBBLE, OR LESS). THE FACILITY DETERMINED THAT THIS WAS AN ISSUE WITH THEIR HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10748122 ↗
• MalfunctionOct 28, 2020Vibration; Vibration

  EACH OF THE REPORTED BURS THAT WOBBLED WERE INITIAL USE, NOT REPROCESSED, AND SOME WOBBLED RIGHT OUT OF THE PACKAGE. TO TROUBLESHOOT THE ISSUE, THE DOCTOR TRIED USING THE BURS IN DIFFERENT HANDPIECES, TO SEE THE RESULT. EACH OF THE BURS WOBBLED IN A SECOND HANDPIECE; HOWEVER, IT WAS FOUND THAT THERE WAS VARIABILITY ON HOW MUCH OF A WOBBLE WAS EVIDENT WITH EACH HANDPIECE (EITHER MORE WOBBLE, OR LESS). THE FACILITY DETERMINED THAT THIS WAS AN ISSUE WITH THEIR HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10747944 ↗