FMS 283479Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705025435), received between Sep 17, 2019 and Feb 5, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Break

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A JOINT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.0MM ROUND TRDO BURR PLUS 5PK DEVICE ANCHOR BROKE OFF AND METAL SHAVINGS FELL OFF. ALL BROKEN PARTS WERE REMOVED. THE METAL SHAVINGS THAT FELL OFF WERE FOUND ON THE BURR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268722 ↗
• MalfunctionDec 28, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 4.0MM ROUND TRDO BURR PLUS DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031624 ↗
• MalfunctionOct 24, 2024Mechanical Jam; Noise, Audible; Mechanical Jam; Noise, Audible

  IT WAS REPORTED FROM BRAZIL THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE 4.0MM ROUND TRDO BURR PLUS 5PK DEVICE WAS STUCK IN THE HANDPIECE. ACCORDING TO THE REPORTER, THE SURGEON PLACED THE BONE BLADE IN THE HANDPIECE WHICH ROTATES. HOWEVER, WHEN THE SHAVER BLADE WAS FITTED IT DID NOT WORK. THE DEVICE INCLUDES AN IRON CANNULA AND A DRILL THAT ROTATES WHEN CONNECTED TO THE MOTOR, BUT THE DRILL BECAME JAMMED WITH THE BLADE. DESPITE ATTEMPTS TO UNLOCK IT, INCLUDING USING A SOLUTION, THE ISSUE PERSISTED. AS A RESULT, THE DOCTOR WAS UNABLE TO USE IT. WHEN THEY INSERTED IT INTO THE CAVITY AND SQUEEZED THE TRIGGER, THE DEVICE BEGAN TO BEEP. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525185 ↗
• MalfunctionDec 5, 2022Mechanical Problem; Device Damaged Prior to Use; Mechanical Problem; Device Damaged Prior to Use

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4 MM ROUND TORNADO BURR PLUS DEVICE WAS STUCK UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION OF THE VIDEO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE BURR APPEARED TO BE JAMMED AND NOT ABLE TO ROTATE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916544 ↗
• MalfunctionNov 7, 2022Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A KNEE SURGERY ON (B)(6) 2022. IT WAS OBSERVED THAT THE 4 MM ROUND TORNADO BURR PLUS DEVICE DID NOT FUNCTION AT ALL AFTER CONNECTING WITH THE GENERATOR WHICH THE SCREEN DID NOT SHOW ANY ALERT CODE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE INNER SHAFT WAS SEIZED; AND THAT IT WAS NOT POSSIBLE TO SPIN TO ANY DIRECTION OR SEPARATE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744949 ↗
• MalfunctionOct 12, 2022Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A KNEE PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4 MM ROUND TORNADO BURR PLUS DEVICE DID NOT FUNCTION AFTER IT WAS CONNECTED TO A GENERATOR. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT IT WAS NOT POSSIBLE TO MOVE THE INNER FROM THE OUTER AS IT WAS JAMMED. 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 15591706 ↗
• MalfunctionFeb 8, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPY SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TERMINAL OF MOTOR ON THE 4.0MM ROUND TRDO BURR PLUS DEVICE SEIZED UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13482977 ↗
• MalfunctionSep 17, 2019Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, SMALL PARTICLES CAME LOOSE. THEREFOR, THE PROCEDURE WAS PROLONGED. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 9079016 ↗