NA 7205668Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010293084), received between Sep 19, 2017 and Jan 5, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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.

• MalfunctionJan 5, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE ACROMIOBLASTER 4.0MM EP-1 DSPL BLADE WAS FOUND TO HAVE A HAIR INSIDE THE MAIN PACKAGING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT 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 11120904 ↗
• MalfunctionMay 26, 2019Overheating of Device; Vibration; Noise, Audible

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE MOTOR DRIVE UNIT HEATED UP AND VIBRATED WITH A STRANGE NOISE. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE, WITHOUT DELAY, THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8643131 ↗
• MalfunctionJan 10, 2018Melted

  IT WAS REPORTED THAT THE PLASTIC ON BURR MELTED, IT WAS INFORMED THAT THE SURGEON WAS USING THE BURR IN AN OPEN SITUATION. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7178280 ↗
• MalfunctionSep 19, 2017Metal Shedding Debris

  IT WAS REPORTED THAT THE SHAVER WAS PROVIDING MULTIPLE METALSHAVINGS. ALL VISUAL METAL PARTS WERE REMOVED FROM THE PATIENT. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6875356 ↗