FMS 283889Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10886705022106), received between Oct 29, 2018 and Sep 12, 2024 — classified as 2 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (59 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Break; Device Contaminated During Manufacture or Shipping; Break; Device Contaminated During Manufacture or Shipping

  REPORT 2 OF 2 FOR THE EVENT. IT WAS REPORTED BY THE SALES REP IN BELGIUM THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT TWO BARREL TORNADO BURR PLUS DEVICES BROKE IN THE PROXIMAL PART AND ONE BLADE LEFT A METALLIC DEPOSIT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200967 ↗
• MalfunctionJul 10, 2023Break; Infusion or Flow Problem; Break; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5 MM BARREL TORNADO BUR PLUS DEVICE WAS BLOCKED AFTER USING IT FOR SOME MINUTES. ACCORDING TO THE REPORT, THE SURGEON TOOK BOTH PARTS APART TO MAKE AN INSPECTION AND BLACK LITTLE PIECES CAME OUT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17291594 ↗
• MalfunctionJun 14, 2023Infusion or Flow Problem; Mechanical Jam; Infusion or Flow Problem; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5 MM BARREL TORNADO BUR PLUS DEVICE WAS BLOCKED AFTER SOME MINUTES OF USING IT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17127924 ↗
• MalfunctionJun 14, 2023Infusion or Flow Problem; Mechanical Jam; Infusion or Flow Problem; Mechanical Jam

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5 MM BARREL TORNADO BUR PLUS DEVICE WAS BLOCKED AFTER SOME MINUTES OF USING IT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17127922 ↗
• MalfunctionJun 8, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5 MM BARREL TORNADO BUR PLUS DEVICE WAS BLOCKED AFTER FIVE MINUTES OF USE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17089741 ↗
• MalfunctionJun 8, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5 MM BARREL TORNADO BUR PLUS DEVICE WAS BLOCKED AFTER FIVE MINUTES OF USE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17089466 ↗
• MalfunctionAug 25, 2022Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INNER PART ON THE 5 MM BARREL TORNADO BUR PLUS DEVICE DID NOT ROTATE ANYMORE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE INNER SHAFT WAS SEIZED THAT IT WAS NOT POSSIBLE TO SPIN TO ANY DIRECTION OR SEPARATE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293615 ↗
• MalfunctionJul 5, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN THAT DURING A SHOULDER DECOMPRESSION AND ARTHROSCOPIC ACROMIO-CLAVICULAR (ACJ) EXCISION, IT WAS OBSERVED THAT THERE WERE METAL FILINGS LEFT IN THE JOINT WHILE USING THE 5.0 MM BARREL BURR PLUS BLADE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14917466 ↗
• MalfunctionMar 18, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WAS BLOCKED AND DID NOT ROTATE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804666 ↗
• MalfunctionFeb 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM BLADE DEVICE DID NOT FIT INTO THE HANDPIECES. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A DELAY OF FIVE MINUTES TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481033 ↗
• MalfunctionFeb 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM BLADE DEVICE DID NOT FIT INTO THE HANDPIECES. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A DELAY OF FIVE MINUTES TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481032 ↗
• MalfunctionFeb 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM BLADE DEVICE DID NOT FIT INTO THE HANDPIECES. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A DELAY OF FIVE MINUTES TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481021 ↗
• MalfunctionDec 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE BARREL TORNADO BURR 5.5MM BLADE DEVICE DID NOT FIT WELL WITH THE HANDPIECE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931399 ↗
• MalfunctionDec 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE BARREL TORNADO BURR 5.5MM BLADE DEVICE DID NOT FIT WELL WITH THE HANDPIECE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931398 ↗
• MalfunctionDec 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM BLADE DEVICE WOULD NOT ENGAGE CORRECTLY WITH THE HANDPIECE; AND THAT IT WOULD CUT IN AND OUT DURING USE AS IT WAS NOT FULLY CLICKED IN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919080 ↗
• MalfunctionDec 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WOULD NOT ENGAGE CORRECTLY WITH THE SHAVER HANDPIECE THEN WOULD CUT IN AND OUT DURING USE AS IT WAS NOT FULLY CLICKED IN. THE SURGERY WAS COMPLETED SUCCESSFULLY BUT WAS DELAYED A COUPLE OF MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12912555 ↗
• MalfunctionDec 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WOULD NOT ENGAGE CORRECTLY WITH THE SHAVER HANDPIECE THEN WOULD CUT IN AND OUT DURING USE AS IT WAS NOT FULLY CLICKED IN. THE SURGERY WAS COMPLETED SUCCESSFULLY BUT WAS DELAYED A COUPLE OF MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12912543 ↗
• MalfunctionDec 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WOULD NOT ENGAGE CORRECTLY WITH THE SHAVER HANDPIECE THEN WOULD CUT IN AND OUT DURING USE AS IT WAS NOT FULLY CLICKED IN. THE SURGERY WAS COMPLETED SUCCESSFULLY BUT WAS DELAYED A COUPLE OF MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12912542 ↗
• MalfunctionDec 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN AUSTRALIA THAT DURING AN ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WOULD NOT ENGAGE CORRECTLY WITH THE SHAVER HANDPIECE THEN WOULD CUT IN AND OUT DURING USE AS IT WAS NOT FULLY CLICKED IN. THE SURGERY WAS COMPLETED SUCCESSFULLY BUT WAS DELAYED A COUPLE OF MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12912534 ↗
• MalfunctionDec 1, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WOULD NOT ENGAGE CORRECTLY WITH THE SHAVER HANDPIECE THEN WOULD CUT IN AND OUT DURING USE AS IT WAS NOT FULLY CLICKED IN. THE SURGERY WAS COMPLETED SUCCESSFULLY BUT WAS DELAYED A COUPLE OF MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12912533 ↗
• MalfunctionNov 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WOULD NOT SNAP ONTO THE SHAVER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745269 ↗
• MalfunctionNov 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WOULD NOT SNAP ONTO THE SHAVER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745262 ↗
• MalfunctionOct 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN FRANCE THAT DURING AN ACROMIOPLASTY SHOULDER ARTHROSCOPY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WAS VERY DIFFICULT TO ENGAGE ONTO THE HANDPIECE; AND THAT IT DID NOT HOLD. THE SURGEON WAS FORCED TO HOLD THE SHAVER RING TO FINISH THE ACROMIOPLASTY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706267 ↗
• MalfunctionOct 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN FRANCE THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WAS DEFECTIVE; AND THAT IT COULD NOT SNAP ONTO THE HANDPIECE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706265 ↗
• MalfunctionOct 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN FRANCE THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 5.5MM DEVICE WAS DEFECTIVE; AND THAT IT COULD NOT SNAP ONTO THE HANDPIECE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF LESS THAN FIVE MINUTES. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706224 ↗