NA 7205327Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010251558), received between May 22, 2018 and Dec 26, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THREE (3) ACROMIONIZER BLADES FROM THE SAME BOX PRODUCED METAL SHAVINGS DURING MILLING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897797 ↗
• MalfunctionDec 9, 2025Flaked; Flaked

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT TWO (2) ACROMIONIZER BLADES RELEASED METALLIC PARTICLES. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758490 ↗
• InjuryDec 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AT THE END OF A SHOULDER ARTHROSCOPY, IT WAS NOTICED THAT THE ACROMIONIZER APPEARED TO LEAVE A BURN ON THE PATIENT AT THE ENTRY SITE OF THE BURR. THE PROCEDURE HAD ALREADY BEEN COMPLETED WITHOUT DELAY USING THE SAME 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: Burn(s)

  MAUDE report 9442958 ↗
• MalfunctionMay 28, 2019Material Fragmentation

  IT WAS REPORTED THAT DURING THE SURGERY SOME BLUE DÉBRIS WERE WITHIN THE PATIENT'S SHOULDER. THE SURGEON WAS ABLE TO RETRIEVE SOME OF IT. IT IS UNKNOWN IF THE DEBRIS CAME FROM THE BLADE. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8647912 ↗
• MalfunctionJan 23, 2019Material Fragmentation

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY, BLUE PLASTIC SHAVINGS WERE INTO THE JOINT. PLASTIC WAS DIRECTLY FROM THE BLUE PLASTIC ON THE BURR. ALL PLASTIC PIECES WERE SHAVED OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270047 ↗
• MalfunctionDec 10, 2018Material Fragmentation

  IT WAS REPORTED THAT, DURING A SHOULDER SAD, THE BURR SEEMED TO BIND UP AT THE BLUE HUB AND BLUE; SHAVINGS FROM THE PLASTIC CAME UP FROM THE HUB AND INTO THE JOINT,. METAL FRAGMENTS WERE CLEANED OUT FROM THE JOINT BY FLUSHING. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NEITHER DELAY NOR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8149402 ↗
• MalfunctionAug 20, 2018Material Disintegration

  IT WAS REPORTED THAT THE DEVICE PUT METAL SHAVINGS INTO THE JOINT WHILE IN USE. ALL THE PIECES WERE REMOVED. 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 7797009 ↗
• MalfunctionJun 19, 2018Noise, Audible

  IT WAS REPORTED THAT WHEN THE BURR WAS SWITCHED ON, IT WAS VERY NOISY, GRATING AND SCRAPING. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613813 ↗
• MalfunctionJun 7, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE BURR RUBS AGAINST THE SHEATH. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED. THERE WAS NO SIGNIFICANT DELAY AND BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7580850 ↗
• MalfunctionMay 22, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE BURR RUBBED AGAINST THE METAL OUTER TUBE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7534382 ↗