Arthrex® AR-8550PRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867044067), received between Mar 22, 2021 and Jan 23, 2023 — classified as 3 malfunctions.

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

• MalfunctionJan 23, 2023Break; Defective Device

  IT WAS REPORTED ON 01/06/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8550PR POWERRASP FELL APART. CASE INVOLVEMENT, DEVICE BROKE DURING USE. THIS ITEM WAS FOUND TO BREAK HALFWAY THROUGH THE PROCEDURE, WHERE WE THEN OPENED UP ANOTHER RASP OF THE SAME LOT NUMBER, AND INSERTED THAT INTO THE SHAVER HANDLE AFTER WE EXTRACTED SOME OF THE RED PIECES OF PLASTIC THAT WERE STUCK IN THE SHAVER HANDLE, I THEN LOWERED THE RPMS TO 5500 AND WE BEGAN TO USE THE RASP AGAIN AND A SECOND TIME THIS ITEM FAILED WHERE THE RED PLASTIC SHE¿S BROKE INSIDE THE SHAVER HANDLE. WE THEN HAD TO EXTRACT A PLASTIC PIECES OUT OF THE SHAVER HANDLE AND WE SWITCH TO A REGULAR BURR TO FINISH THE CASE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223475 ↗
• MalfunctionJan 4, 2022Break; Device Emits Odor; Temperature Problem; Excessive Heating; Excessive Heating

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA E-MAIL THAT AN AR-8550PR POWERASP WAS USED WITH REVOLUTIONS AT 4000 RPM, IT STARTS TO HEAT UP AND BREAKS. THIS WAS DISCOVERED DURING AN ANKLE OSTEOSYNTHESIS ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-8550PR. ADDITIONAL INFORMATION PROVIDED 12/22/21: THE BASE OF THE BLADE BROKE THE ¿TORQUE¿ THAT GIVES IT MOVEMENT. THE AR-8550PR STOPPED WORKING INSIDE THE PATIENT, BUT WHEN THE SURGEON REMOVED THE DEVICE TO CHECK IT, THEY NOTICED THAT IT WAS BURNED AND THE BLADE DETACHES FROM THE TORQUE EASILY. THERE WERE NO BURNS TO THE PATIENT OR STAFF. AS SOON AS THEY NOTICED THE SLIGHTEST CHANGE IN TEMPERATURE AND THE SMELL OF BURNING, THEY STOPPED USING IT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154743 ↗
• MalfunctionMar 22, 2021Material Fragmentation

  IT WAS REPORTED THAT DURING BIG TOE BASE JOINT RIZARTHROSIS WHILE REMOVING THE BONE THE DEVICE PRODUCED METAL DEBRIS. IT WAS FURTHER REPORTED THAT FRAGMENTS REMAINED INSIDE THE JOINT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11540235 ↗