DYONICS 7205326Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 03596010251541), received between Nov 27, 2017 and Feb 3, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING A PROCEDURE, WHILE USING AN ACROMIONIZER 4.0 EP-1 DSPL BL A SMALL AMOUNT OF METAL DEBRIS FELL OFF. THE DEBRIS WAS REMOVED FROM THE PATIENT WITH A LARGE AMOUNT OF PHYSIOLOGICAL SALINE. THE BLADE WAS REPLACED. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247359 ↗
• MalfunctionNov 5, 2025Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER CLEANING PROCEDURE, THE ACROMIONIZER BLADE BECAME SEPARATED INSIDE AND OUTSIDE; THE INNER BLADE CAME OUT AND WAS UNABLE TO FUNCTION AS A GRINDING HEAD. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP AFTER A SURGICAL DELAY GREATER THAN 30 MIN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479560 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE DOCTOR WAS USING THE ACROMIONIZER, THERE WAS A LOUD SQUEAKING NOISE. AFTER REMOVING THE INSERT, THE NURSES DISCOVERED THE INSERT WAS BROKEN WITH SHARDS REMAINING IN THE SHAVER HANDPIECE. PREVIOUSLY WHEN USING THE HANDPIECE WITH 4.5MM BONE CUTTER, THERE WAS NO ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY OF 1-30 MIN. ALL PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984188 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE DOCTOR WAS USING THE ACROMIONIZER, THERE WAS A LOUD SQUEAKING NOISE. AFTER REMOVING THE INSERT, THE NURSES DISCOVERED THE INSERT WAS BROKEN WITH SHARDS REMAINING IN THE SHAVER HANDPIECE. IT WAS THEN SWITCHED TO ANOTHER HANDPIECE WITH THE SAME INSERT, BUT THERE IS STILL SQUEAKING SOUND UNTIL 1 MINUTE INTO BURRING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978600 ↗
• MalfunctionFeb 5, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT DURING SET UP, THE SEALED PACKAGING OF THE ACROMIONIZER BLADE WAS DAMAGED AND DEFORMED, AND THE STERILE BARRIER WAS COMPROMISED. THERE WAS A BACK-UP DEVICE AVAILABLE, AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318323 ↗
• MalfunctionApr 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP IT WAS FOUND THAT THE INNER PACKAGING OF TWO (2) ACROMIONIZER WERE DAMAGED AND COULD NOT BE USED. THERE WAS A BACK-UP DEVICE AVAILABLE AND A SURGICAL DELAY LESS THAN 30 MINUTES WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140821 ↗
• MalfunctionApr 18, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT DURING SET UP IT WAS FOUND THAT THE INNER PACKAGING OF THE ACROMIONIZER WAS DAMAGED AND COULD NOT BE USED. THERE WAS A BACK-UP DEVICE AVAILABLE AND A SURGICAL DELAY LESS THAN 30 MINUTES WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140344 ↗
• MalfunctionOct 11, 2023Break; Break

  IT WAS REPORTED THAT THE CUSTOMER REPORTED THAT THERE WAS A BREAKAGE DURING THE HANDLING OF THE ACROMIONIZER. A NON-SIGNIFICANT DELAY WAS REPORTED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916894 ↗
• InjuryAug 5, 2021Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT, DURING A CUFF REPAIR, 3 ACROMIONIZER BLADES WERE MAKING CONTACT AGAINST THE SHEATH. THERE WAS LITTLE METAL POWDER PEELED OFF, WHICH WAS REMOVED BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. A DELAY OF MORE THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285703 ↗
• MalfunctionAug 5, 2021Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT, DURING A CUFF REPAIR, 3 ACROMIONIZER BLADES WERE MAKING CONTACT AGAINST THE SHEATH. THERE WAS LITTLE METAL POWDER PEELED OFF, WHICH WAS REMOVED BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. A DELAY OF MORE THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285701 ↗
• MalfunctionAug 5, 2021Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  IT WAS REPORTED THAT, DURING A CUFF REPAIR, 3 ACROMIONIZER BLADES WERE MAKING CONTACT AGAINST THE SHEATH. THERE WAS LITTLE METAL POWDER PEELED OFF, WHICH WAS REMOVED BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. A DELAY OF MORE THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285697 ↗
• MalfunctionDec 27, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ACROMIONIZER BROKE OFF INSIDE THE PATIENT AND THE BROKEN PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED. 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 9527680 ↗
• MalfunctionOct 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT BEFORE WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THE PRODUCT END BROKEN. NO PATIENT INVOLVED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT WAS USED IN A SURGERY AND THE INNER AND OUTER COMPONENTS HAD EVIDENCE OF HAVING BECOME MELTED, SEIZED UP AND SUBSEQUENTLY BROKEN AND PIECES SEPARATED WHICH MAKES IT A RE-PORTABLE 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 9251081 ↗
• MalfunctionAug 22, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE OVERHEATED. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8920322 ↗
• MalfunctionFeb 6, 2019Dull, Blunt

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADES WERE BLUNT, THE SURGEON HAD TO EXERT EXTREME PRESSURE ON THE CUTTING BLADE. THIS RESULTS IN METAL ABRASION. THROUGH FLUSHING EVERYTHING WAS REMOVED. NO SIGNIFICANT DELAYS REPORTED. BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8313410 ↗
• MalfunctionFeb 6, 2019Dull, Blunt

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADES WERE BLUNT, THE SURGEON HAD TO EXERT EXTREME PRESSURE ON THE CUTTING BLADE. THIS RESULTS IN METAL ABRASION. THROUGH FLUSING EVERYTHING WAS REMOVED. NO SIGNIFICANT DELAYS REPORTED. BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8313404 ↗
• MalfunctionFeb 6, 2019Dull, Blunt

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADES WERE BLUNT, THE SURGEON HAD TO EXERT EXTREME PRESSURE ON THE CUTTING BLADE. THIS RESULTS IN METAL ABRASION. THROUGH FLUSHING EVERYTHING WAS REMOVED. NO SIGNIFICANT DELAYS REPORTED. BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8313396 ↗
• MalfunctionFeb 6, 2019Dull, Blunt

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADES WERE BLUNT, THE SURGEON HAD TO EXERT EXTREME PRESSURE ON THE CUTTING BLADE. THIS RESULTS IN METAL ABRASION. THROUGH FLUSHING EVERYTHING WAS REMOVED. NO SIGNIFICANT DELAYS REPORTED. BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8313390 ↗
• MalfunctionDec 7, 2018Overheating of Device

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE HAD AN OVERHEATING.THE PROCEDURE WAS COMPLETED WITH THE BACK-UP DEVICE, NO PATIENT INJURIES AND COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8142708 ↗
• MalfunctionAug 24, 2018Material Disintegration

  IT WAS REPORTED THAT WHEN THE SURGEON WAS USED THE NEW PROBE, A LOT OF METAL DEBRIS FELL OFF. THE SURGEON CONTINUED TO USE THE AFFECTED PRODUCT TO CONTINUE THE SURGERY, AT LAST USED A BLADE TO CLEAN UP ALL THE DEBRIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7814697 ↗
• MalfunctionAug 23, 2018Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT WHEN THE SURGEON WAS USED THE NEW PROBE, A LOT OF METAL DEBRIS FELL OFF. THE SURGEON CONTINUED TO USE THE AFFECTED PRODUCT TO CONTINUE THE SURGERY, AT LAST USED A BLADE TO CLEAN UP ALL THE DEBRIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7810108 ↗
• MalfunctionJul 12, 2018Material Disintegration

  IT WAS REPORTED LOST OF METAL BLADE FRAGMENTS IN THE PATIENT WHILE SCRAPING THE BONE. IT IS UNKNOWN IF ALL THE FRAGMENTS WERE REMOVED FROM THE PATIENT. NO SIGNIFICANT PROCEDURE DELAY WAS REPORTED. BACK UP DEVICE WAS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7681989 ↗
• MalfunctionMay 18, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING PROCEDURE THE ACROMIONIZER DEVICE PRESENTED ITS BLADE RIBBING AGAINST THE METAL SHEATH WITH NO SHEDDING OR FLAKING. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES. PER CUSTOMER¿S RESPONSE THE DEVICE RAN CONTINOUSLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7526697 ↗
• MalfunctionNov 27, 2017Melted; Overheating of Device

  IT WAS REPORTED THAT WHEN USED A PROBE DURING A SURGERY, FOUND THE PART OF PROBE APPROACHING THE HANDLE SHANK MELTED. THEN THREE PROBES WITH SAME LOT NUMBER WERE USED TO THE SURGERY, BUT SIMILAR PROBLEMS OCCURRED. TOTAL 4 PROBES FAILED AND WERE OVERHEATING. FINALLY A DIFFERENT LOT NUMBER SAME CODE NUMBER DEVICE WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7061607 ↗
• MalfunctionNov 27, 2017Melted; Overheating of Device

  IT WAS REPORTED THAT WHEN USED A PROBE DURING A SURGERY, FOUND THE PART OF PROBE APPROACHING THE HANDLE SHANK MELTED. THEN THREE PROBES WITH SAME LOT NUMBER WERE USED TO THE SURGERY, BUT SIMILAR PROBLEMS OCCURRED. TOTAL 4 PROBES FAILED AND WERE OVERHEATING. FINALLY A DIFFERENT LOT NUMBER SAME CODE NUMBER DEVICE WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7061605 ↗