FMS 283869Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705023080), received between Mar 14, 2018 and Oct 10, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (10 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.

• MalfunctionOct 10, 2023Break; Mechanical Jam; Break; 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 5.0 MM BARREL BURR PLUS DEVICE WAS BLOCKED WHILE IN USE WITH AN UNKNOWN HANDPIECE DEVICE. CHANGED TO ANOTHER DEVICES BUT HAD THE SAME ISSUE. IT WAS FURTHER REPORTED THAT FRAGMENTS WERE GENERATED. 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 17907285 ↗
• MalfunctionOct 10, 2023Break; Mechanical Jam; Break; 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 5.0 MM BARREL BURR PLUS DEVICE WAS BLOCKED WHILE IN USE WITH AN UNKNOWN HANDPIECE DEVICE. CHANGED TO ANOTHER DEVICES BUT HAD THE SAME ISSUE. IT WAS FURTHER REPORTED THAT FRAGMENTS WERE GENERATED. 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 17907283 ↗
• MalfunctionAug 18, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INNER AND OUTER BLADES ON THE 5.0 MM BARREL BURR PLUS DEVICE WERE BLOCKED. 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 17572869 ↗
• MalfunctionJul 13, 2023Device Contaminated During Manufacture or Shipping; Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Device Contaminated During Manufacture or Shipping; Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5.0 MM BARREL BURR PLUS DEVICE WAS BLOCKED. IT WAS FURTHER REPORTED THAT WHEN SEPARATING INNER PART FROM OUTER PART. THEY HAD PIECES THAT RUBBED OFF. 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 17321574 ↗
• MalfunctionJul 13, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5.0 MM BARREL BURR PLUS DEVICE WAS BLOCKED. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17321477 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN BRAZIL THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5.0 MM BARREL BURR PLUS DEVICE BROKE. 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 17072942 ↗
• MalfunctionAug 9, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING A SHOULDER DECOMPRESSION AND ACROMIOCLAVICULAR JOINT (ACJ) EXCISION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE METAL FILLINGS LEFT IN THE JOINT WHILE USING 5.0 MM BARREL BURR PLUS DEVICE. 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 15190821 ↗
• MalfunctionAug 9, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING A SHOULDER DECOMPRESSION AND ACROMIOCLAVICULAR JOINT (ACJ) EXCISION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE METAL FILLINGS LEFT IN THE JOINT WHILE USING 5.0 MM BARREL BURR PLUS DEVICE. 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 15190818 ↗
• MalfunctionJul 5, 2022Break; Break

  THIS IS REPORT 1 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14917474 ↗
• MalfunctionJul 5, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THERE WERE METAL PARTICULATES/SHRAPNELS THAT HAD COME OFF THE SHAVER INTO THE PATIENTS JOINT WHILE USING THE 5.0 MM BARREL BURR PLUS DEVICE. ACCORDING TO THE REPORT, IT WAS DEALT WITH IN LESS THAN FIVE MINUTES WITH SUCTION CLEARANCE OF THE JOINT USING A SHAVER BLADE. 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 14916604 ↗
• MalfunctionFeb 7, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE FEW METAL PARTS IN THE SHOULDER JOINT WHILE USING THE 5.0 MM BARREL BURR PLUS BLADE DEVICE. ACCORDING TO THE REPORTER, IT WAS UNKNOWN IF ALL FRAGMENTS WERE REMOVED FROM THE PATIENT'S BODY. THERE WAS NO PROCEDURE SCHEDULED TO REMOVE FRAGMENTS. 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 13472784 ↗
• MalfunctionFeb 4, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY AFFILIATE VIA EMAIL, THAT DURING AN ARTHROSCOPY, THE BLADE OF A 5.0 MM BARREL BURR PLUS WAS JAMMED. PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9667861 ↗
• MalfunctionSep 5, 2018Break; Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DURING A SHOULDER REPAIR THAT THE CUSTOMER'S MICRO HANDPIECE WAS WORKING INTERMITTENTLY. THE SURGEON REMOVED THE BURR FROM THE DEVICE AND HEARD A SNAP. A SMALL PLASTIC PIECE FELL OUT OF THE DEVICE FOLLOWED BY THE TISSUE SEAL. THE SURGEON PLACED THE BURR BACK INTO THE DEVICE AND FINISHED THE PROCEDURE WITH THE SAME DEVICES WITH NO PATIENT CONSEQUENCES. THE SALES REP REPORTED A 5 MINUTE DELAY IN THE PROCEDURE. THE BURR WAS ALREADY DISCARDED BUT THE CUSTOMER WILL BE RETURNING THE HANDPIECE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7848086 ↗
• MalfunctionMar 14, 2018Break; Metal Shedding Debris; Break; Metal Shedding Debris

  IT WAS REPORTED BY THE AFFILIATE THAT THERE WAS BROKEN METAL SWARF INTO THE SHOULDER JOINT ON SEVERAL OCCASIONS. THE JOINT WAS CLEANED OUT WITH SUCTION. THERE WAS A FIVE MINUTE DELAY TO THE PROCEDURE. THERE WAS NO PATIENT HARM. THE CASE COULD BE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7338082 ↗