NA 72200724Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 03596010578020), received between Nov 23, 2018 and Aug 3, 2023 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (9 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2023Material Deformation; Noise, Audible; Material Deformation; Noise, Audible

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, FIVE (5) DYONICS ACROMIONIZER BURRS WERE MAKING A STRANGE NOISE AND THE TERMINAL FUSED. SURGERY WAS COMPLETED AFTER A SIGNIFICANT DELAY (>30 MIN) USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454747 ↗
• MalfunctionJul 12, 2023Melted; Melted

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, TWO (2) ACROMIONIZER BURR FAILED. THE ACROMIONIZER BURRS HAD A STRANGE NOISE, AFTER THAT THEY MELTED AND BROKE IN THE PART WHERE THEY ARE CONNECTED TO THE MDU. ONE DEVICE STOPPED BEFORE BREAKAGE, BUT IT IS UNKNOWN WHICH ONE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309730 ↗
• MalfunctionMar 6, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN TWO (2) DYONICS BLADES WERE ATTACHED TO A SHAVER HANDPIECE AND ROTATED THEY MADE A STRANGE NOISE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 45 MINUTES DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484726 ↗
• MalfunctionMay 23, 2022Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY TWO BLADES MADE A STRANGE NOISE. IT OCCURRED AFTER ABOUT 10 SECONDS OF ROTATION. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO PATIENT COMPLICATIONS WERE REPORTED. OVERHEATING WAS REPORTED ON DEVICE WITH THE LOT NUMBER 50943904.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470601 ↗
• MalfunctionAug 26, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN OPENING THE PACKAGE OF THE DYONICS ACROMIONIZER BURR IT WAS FOUND THAT THE STERILIZATION TRAY ACCIDENTALLY CONTAINED AN ABRADER BURR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370336 ↗
• InjuryJan 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DYONICS ACROMIONIZER BURR 4MM INNER AND OUTER SHEATHS MELDED TOGETHER. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY USING A 5.5 MM BURR WITH THE SAME HANDPIECE AS A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11120963 ↗
• InjuryJan 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DYONICS ACROMIONIZER BURR 4MM INNER AND OUTER SHEATHS MELDED TOGETHER. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY USING A 5.5 MM BURR WITH THE SAME HANDPIECE AS A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11120901 ↗
• InjuryJan 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DYONICS ACROMIONIZER BURR 4MM INNER AND OUTER SHEATHS MELDED TOGETHER. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY USING A 5.5 MM BURR WITH THE SAME HANDPIECE AS A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11120812 ↗
• InjuryJan 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE DYONICS ACROMIONIZER BURR 4MM INNER AND OUTER SHEATHS MELDED TOGETHER. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY USING A 5.5 MM BURR WITH THE SAME HANDPIECE AS A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11120705 ↗
• MalfunctionOct 7, 2020Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED THAT DURING A BONE BLOCK SURGERY, WHILE USING THE BURR AND HUB, THEY SNAPPED OFF INTO TWO PIECES AFTER BEING USED FOR UNDER 1 MINUTE, THE DEVICE DID NOT BREAK INSIDE THE PATIENT AND THERE WAS NO SHEDDING OR FLAKING DUE TO THIS MALFUNCTION. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT OVERHEATED DUE TO AN INADEQUATE IRRIGATION FLOW WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10643606 ↗
• MalfunctionJun 24, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING ARTHROSCOPY, THE DYONICS BURR COULD NOT BE ROTATED WHEN THE DEVICE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A S+N BACK-UP. NO PATIENT INJURIES OR DELAY WERE REPORTED. BASED ON THE RESULTS OF INVESTIGATION THE BURR OVERHEATED AND HAD MELTED COMPONENTS THIS MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10193036 ↗
• MalfunctionDec 4, 2018Mechanical Problem; Failure to Cut

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONECUTTER TO TAKE SOME OF THE BONE. THE BONECUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8129319 ↗
• MalfunctionDec 4, 2018Material Disintegration

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONECUTTER TO TAKE SOME OF THE BONE. THE BONECUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8129019 ↗
• MalfunctionDec 4, 2018Failure to Cut

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONECUTTER TO TAKE SOME OF THE BONE. THE BONECUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8128897 ↗
• MalfunctionNov 23, 2018Material Fragmentation; Failure to Cut

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100087 ↗
• MalfunctionNov 23, 2018Material Fragmentation

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100084 ↗
• MalfunctionNov 23, 2018Material Fragmentation; Failure to Cut

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100082 ↗
• MalfunctionNov 23, 2018Material Fragmentation

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100081 ↗
• MalfunctionNov 23, 2018Peeled/Delaminated; Failure to Cut

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100071 ↗
• MalfunctionNov 23, 2018Defective Device

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8100069 ↗
• MalfunctionNov 23, 2018Material Fragmentation; Failure to Cut

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100065 ↗
• MalfunctionNov 23, 2018Material Fragmentation; Failure to Cut

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100063 ↗
• MalfunctionNov 23, 2018Material Fragmentation; Failure to Cut

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100013 ↗
• MalfunctionNov 23, 2018Material Fragmentation

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100006 ↗
• MalfunctionNov 23, 2018Material Fragmentation

  IT WAS REPORTED THAT IT TAKES A LOT OF EFFORT FOR THE BONE CUTTER TO TAKE SOME OF THE BONE. THE BONE CUTTER BLADE PRODUCED SMALL CHIPS OF METAL IN THE JOINT. THEY WERE REMOVED BY FLUSHING OUT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8100001 ↗