NA 72200730Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010578082), received between Feb 25, 2019 and Jul 26, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Melted; Noise, Audible; Melted; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ACROMIOBLASTER BURR MADE WEIRD NOISES DURING USE, AND THE TERMINAL MELTED. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397732 ↗
• MalfunctionSep 22, 2020Overheating of Device; Material Twisted/Bent; Overheating of Device; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF BURR WAS BENT WHEN THE BLADE WAS USING IT. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS FINISHED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE SHOWN THAT THE DEVICE OVERHEATED 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 Information

  MAUDE report 10566559 ↗
• MalfunctionFeb 25, 2019Noise, Audible

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE MADE A NOISE WHEN THE DEVICE WAS ROTATING. THE PROCEDURE WAS COMPLETED WITHOUT USING THE DEVICE. DELAY OR PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8368958 ↗