NA 72200731Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010578099), received between Nov 19, 2020 and Apr 27, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Flaked” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE PACKAGING OF THE ACROMIOBLASTER BURR WAS COMPROMISED, IT WAS ALMOST MELTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14224642 ↗
• InjuryNov 19, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING ARTHROSCOPIC SHOULDER SURGERY, THE SURGEON WAS COMPLAINING OF SHEDDING ON THE SHAVER BLADE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO OTHER COMPLICATIONS WERE REPORTED. MINOR DELAY TO CLEAR METAL SHAVINGS FROM JOINT. 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; No Information

  MAUDE report 10871628 ↗
• MalfunctionNov 19, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY, WHEN USING THE ACROMIOBLASTER BURR ON FULL FORWARD, AN EXTREMELY LOUD HIGH PITCH SCREECHING SOUND APPEARED. LIKE THE METAL WAS GRINDING. METAL FRAGMENTS WERE PRESENT, ALTHOUGH THE MALFUNCTION OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING 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 Known Impact Or Consequence To Patient

  MAUDE report 10871480 ↗
• MalfunctionNov 19, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY, WHEN USING THE ACROMIOBLASTER BURR ON FULL FORWARD, AN EXTREMELY LOUD HIGH PITCH SCREECHING SOUND APPEARED. LIKE THE METAL WAS GRINDING. METAL FRAGMENTS WERE PRESENT, ALTHOUGH THE MALFUNCTION OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING 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 Known Impact Or Consequence To Patient

  MAUDE report 10871478 ↗