FMS 283489Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886705022052), received between Oct 29, 2018 and Jul 14, 2025 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (18 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE BARREL TORNADO BURR 4.0MM DEVICE HAD A PIECE OF METALLIC BURR IN THE PATIENT. IT IS UNKNOWN WHETHER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22495886 ↗
• MalfunctionFeb 19, 2025Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT FUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, THE DEVICE WAS TESTED FOR ITS FUNCTIONALITY, THE INNER HUB WAS ATTEMPTED TO BE DISASSEMBLED, HOWEVER IT WAS FOUND TO BE JAMMED. THERE WAS PATIENT INVOLVEMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414288 ↗
• MalfunctionNov 7, 2024Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN SINGAPORE THAT DURING AN ANKLE RECONSTRUCTION SURGERY ON AN UNKNOWN DATE IT WAS OBSERVED THAT THE 2X BARREL TORNADO BURR 4.0MM BLADE DEVICE INNER PIECE WAS NOT SPINNING ON USAGE AND STUCK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628872 ↗
• MalfunctionNov 7, 2024Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN SINGAPORE THAT DURING AN ANKLE RECONSTRUCTION SURGERY ON AN UNKNOWN DATE IT WAS OBSERVED THAT THE 2X BARREL TORNADO BURR 4.0MM BLADE DEVICE INNER PIECE WAS NOT SPINNING ON USAGE AND STUCK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628868 ↗
• MalfunctionSep 12, 2024Break; Device Contaminated During Manufacture or Shipping; Break; Device Contaminated During Manufacture or Shipping

  REPORT 1 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 20201033 ↗
• MalfunctionFeb 7, 2023Infusion or Flow Problem; Mechanical Jam; Infusion or Flow Problem; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN BELGIUM THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 4 MM BARREL TORNADO BUR PLUS DEVICE WAS BLOCKED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 15 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 16311840 ↗
• MalfunctionOct 5, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 4 MM BARREL TORNADO BUR PLUS DEVICE WAS STUCK. 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 15545453 ↗
• MalfunctionAug 8, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO 4 MM BARREL TORNADO BUR PLUS DEVICES WERE BROKEN. 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 15188252 ↗
• MalfunctionAug 8, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO 4 MM BARREL TORNADO BUR PLUS DEVICES WERE BROKEN. 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 15188249 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN THE NETHERLANDS THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THERE WERE METAL PARTICLES CAME LOOSE FROM THE 4 MM BARREL TORNADO BUR PLUS DEVICE. THE PARTICLES WERE FLUSHED OUT OF THE JOINT. THERE WAS AN ADDITIONAL THREE 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 15098055 ↗
• MalfunctionJun 2, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN BELGIUM THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 4.0MM DEVICE WAS BLOCKED AND DID NOT FUNCTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580418 ↗
• MalfunctionJan 27, 2022Degraded; Output Problem; Degraded; Output Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A MENISCAL REPAIR SURGERY ON (B)(6) 2022 IT WAS OBSERVED THAT THE BARREL TORNADO BURR 4.0MM BLADE DEVICE WAS NOT WORKING AS IT WAS UNABLE TO BURR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13368788 ↗
• MalfunctionJan 27, 2022Degraded; Output Problem; Degraded; Output Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A MENISCAL REPAIR SURGERY ON (B)(6) 2022 IT WAS OBSERVED THAT THE BARREL TORNADO BURR 4.0MM BLADE DEVICE WAS NOT WORKING AS IT WAS UNABLE TO BURR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13368766 ↗
• MalfunctionSep 2, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 4.0MM DEVICE SEIZED UP AFTER A SHORT USE. 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 12416154 ↗
• MalfunctionSep 2, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 4.0MM DEVICE SEIZED UP AFTER A SHORT USE. 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 12416117 ↗
• MalfunctionSep 2, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 4.0MM DEVICE SEIZED UP AFTER A SHORT USE. 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 12416099 ↗
• MalfunctionJul 23, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A SHOULDER REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 4.0MM DEVICE STAYED BLOCKED WHEN ACTIVATED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE 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 12219669 ↗
• MalfunctionJun 28, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 4.0MM DEVICE JAMMED AFTER ABOUT 10 MINUTES AND COULD NO LONGER BE MOVED. ANOTHER LIKE DEVICE WAS USED 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 12078880 ↗
• MalfunctionMay 7, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BARREL TORNADO BURR 4.0MM 5PK DEVICE WAS SHAVER BLOCKED AFTER A SHORT TIME OF USE AND COULD NO LONGER BE MOVED. 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 11791722 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED BY AFFILIATE IN (B)(6) THAT DURING, AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE BLADE DEVICE HAD METAL DEBRIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694522 ↗
• MalfunctionMar 30, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE BURR DEVICE HAD A FILM OF PLASTIC WRAPPED AROUND ITS INSIDE SHAFT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590516 ↗
• MalfunctionAug 7, 2020Break; Break

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE, SMALL FRAGMENTS WERE FOUND AT ATTACHMENT END OF A 4 MM BARREL TORNADO BUR PLUS AND IT WAS UNABLE TO ROTATE INNER AND OUTER PIECE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE MALFUNCTION OCCURRED DURING A SHOULDER ARTHROSCOPY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A COMPETITOR'S DEVICE. IT WAS ALSO REPORTED NO FRAGMENTS DROPPED INTO THE PATIENT DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379531 ↗
• MalfunctionMar 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE THE BARREL TORNADO BURR 4.0 MM 5PK REMAINS LOCKED APPROXIMATELY 1 HOUR AFTER THE SURGERY. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED REPORTING THE DEVICE WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9789094 ↗
• InjuryJan 14, 2020Mechanical Jam; Suction Failure; Mechanical Jam; Suction Failure

  IT WAS REPORTED BY AFFILIATE VIA EMAIL, THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY (SUBACROMIAL DECOMPRESSION, CLAVICLE RESECTION) THE SHAVER BLAD STARTED TO SOUND STRANGE, HAD BAD SUCTION AND STOPPED WORKING. WHEN THE BLADE WAS TAKEN OUT OF THE HANDPIECE, THE INNER AND OUTER PARTS WERE STUCK TOGETHER AND COULD NOT BE SEPARATED. THE BLADE WAS REPLACED WITH A SIMILAR ONE, BUT THE PROCEDURE WAS PROLONGED 15 MIN. THE SURGEON EXPERIENCED A BIT MORE SWELLING THAN NORMAL.

  Patient problems: Edema; Not Applicable

  MAUDE report 9588543 ↗
• MalfunctionNov 19, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT BEFORE ROTATOR CUFF SUTURE OPERATION, IT WAS OBSERVED THAT THE INNER PACKING ON THE BARREL TORNADO BURR 4.0MM 5PK WAS DAMAGED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9342980 ↗