Arthrex® AR-8400PRRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867043619), received between Aug 31, 2021 and Aug 13, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Melted; Melted

  ON 08/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT (2) AR-8400PR POWERASP CAME APART. THIS OCCURRED DURING USE THE HOUSING THAT INTERACTS WITH THE SHAVER HANDPIECE MELTED AND DISSEMBLED. THE UNITS FUNCTIONED FINE LONG ENOUGH FOR THE SURGEON TO COMPLETE THE CASE, HOWEVER, THEY THEN STOPPED WORKING AND CAME/MELTED APART.

  Patient problems: Insufficient Information

  MAUDE report 19974609 ↗
• MalfunctionJun 7, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED ON 03/24/2022 BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8400PR POWEERRASP OVERHEATED AND BROKE. THIS OCCURRED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491799 ↗
• MalfunctionJan 3, 2024Melted; Melted

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE HUB OF THE DEVICE MELTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435769 ↗
• MalfunctionDec 3, 2023Break; Break

  IT WAS REPORTED THAT THE GRATER BROKE DURING A SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253509 ↗
• MalfunctionDec 3, 2023Break; Break

  IT WAS REPORTED THAT THE GRATER BROKE DURING A SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253500 ↗
• MalfunctionDec 3, 2023Break; Break

  IT WAS REPORTED THAT THE GRATER BROKE DURING A SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253498 ↗
• MalfunctionAug 4, 2023Melted; Melted

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE POWERASP MELTED AND CAME APART IN THE HAND PIECE. THE SAME THING HAPPENED WITH SECOND ONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH DIFFERENT PART NUMBER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17464679 ↗
• MalfunctionAug 4, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANKLE FUSION SURGERY THE POWERASP MELTED AND CAME APART IN THE HAND PIECE. THE SAME THING HAPPENED WITH SECOND ONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH DIFFERENT PART NUMBER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461978 ↗
• MalfunctionJul 18, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8400BC BONE CUTTER AND AR-8400PR POWERRASP DO NOT WORK. THE SAME PROBLEM CONTINUES 2 TIMES. THIS WAS DISCOVERED DURING A CASE, USED A NEW PRODUCT AND THE CASE IS COMPLETED. NO PATIENT HARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343332 ↗
• MalfunctionSep 14, 2021Thermal Decomposition of Device; Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE SHAVER ATTACHMENT IS SCORCHED / BURNT THROUGH. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12466757 ↗
• MalfunctionAug 31, 2021Loose or Intermittent Connection; Device Slipped; Failure to Cut

  IT WAS REPORTED THAT DURING AN SCR PROCEDURE PERFORMED ON AN (B)(6) YEAR-OLD FEMALE, THE POWERASP WAS UNABLE TO CUT BONE FROM THE START OF THE SURGERY. THE SWIVELOCK FELL OFF AND THE INSERTER SHAFT WAS LOOSE AND NOT FIXED; THE ISSUE DID NOT RESOLVE WHEN IT WAS RETURNED TO THE BASE OF THE INSERTER. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT WITH NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12393511 ↗