Formula 0375941000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327054743), received between Jul 30, 2018 and Mar 25, 2026 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Smoking

  IT WAS REPORTED THAT THERE WAS EXCESSIVE FRICTION AND SMOKE FROM THE MOMENT IT WAS SWITCHED ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691305 ↗
• MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BUR CRACKED AND FILINGS WERE PRESENT IN THE JOINT. THE INTRA-ARTICULAR METAL DEBRIS WAS ASPIRATED AT END OF PROCEDURE. NO CONSEQUENCES TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384266 ↗
• MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BUR CRACKED AND FILINGS WERE PRESENT IN THE JOINT. THE INTRA-ARTICULAR METAL DEBRIS WAS ASPIRATED AT END OF PROCEDURE. NO CONSEQUENCES TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384263 ↗
• MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE BUR CRACKED AND FILINGS WERE PRESENT IN THE JOINT. THE INTRA-ARTICULAR METAL DEBRIS WAS ASPIRATED AT END OF PROCEDURE. NO CONSEQUENCES TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384260 ↗
• InjuryJan 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A SMALL PIECE OF THE TIP OF A BUR BROKE OFF INSIDE A PATIENT. IT WAS NOTED THAT THE BROKEN PIECE MIGHT HAVE BEEN SUCKED OUT, BUT THAT IS NOT CONFIRMED. LOOKED FOR THE PIECE FOR A WHILE AND THEN OPENED UP A NEW BUR. THERE ARE PRESENTLY NO ADVERSE CONSEQUENCES TO THE PATIENT, BUT HARD TO SAY FOR THE LONG TERM NOW.

  Patient problems: Foreign Body In Patient

  MAUDE report 21130578 ↗
• MalfunctionOct 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488097 ↗
• MalfunctionOct 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412305 ↗
• InjurySep 13, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE SHAVER BLADE BROKE IN THE PATIENT'S SHOULDER. THE PIECE OF METAL WAS NEVER RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20212378 ↗
• MalfunctionApr 12, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. PLEASE NOTE, THE DEVICE DID NOT BREAK WITHIN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097422 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074237 ↗
• MalfunctionMay 25, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS A BREACH IN THE STERILE BARRIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005510 ↗
• MalfunctionMay 10, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907212 ↗
• MalfunctionMay 10, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907202 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584721 ↗
• MalfunctionJan 6, 2023Component Misassembled; Break; Component Misassembled

  IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111057 ↗
• MalfunctionSep 28, 2022Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE DEVICE BROKE LEADING TO AN INJURY TO THE MUSCLE OF THE PATIENT.

  Patient problems: Muscle/Tendon Damage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496270 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754600 ↗
• InjuryJun 29, 2021Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE AND A PIECE POTENTIALLY REMAINED IN THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086488 ↗
• MalfunctionJan 8, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.

  Patient problems: No Patient Involvement

  MAUDE report 9564716 ↗
• InjuryMar 26, 2019Break

  PER ADDITIONAL INFORMATION RECEIVED, THE BURS BROKE AT THE PROXIMAL END. THE BURS BREAKING AT THE HUB WOULD CAUSE THE BUR TO BE UNUSABLE BUT WILL NOT CAUSE HARM TO THE PATIENT. THIS SHOULD NOT RESULT IN ANY ADVERSE CONSEQUENCES IF IT WERE TO RECUR. THEREFORE MAKING THIS EVENT NOT REPORTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8453038 ↗
• MalfunctionOct 9, 2018Break

  IT WAS REPORTED THAT THE SHEATH BROKE OFF. NO PIECES FELL INTO THE JOINT SPACE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7949809 ↗
• MalfunctionJul 30, 2018Break

  IT WAS REPORTED THAT THE TIPS BROKE DURING THE PROCEDURE. THE PIECES FELL OFF OUTSIDE OF THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7733065 ↗