Arthrex® AR-8350PRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867043312), received between Apr 26, 2021 and Mar 14, 2024 — classified as 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 3/1/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8350PR POWERASP WOULD NOT RESIZE TO A 4MM DEGREE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. AFTER THE PROCEDURE, THE DEVICE WAS EXAMINED, AND IT WAS DETERMINED THE INNER TUBE COULD NOT MOVE UP OR DOWN. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18905731 ↗
• MalfunctionFeb 20, 2024Break; Break

  ON 2/1/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT WHILE USING A POWERRASP, AR-8350PR, IN AN ANKLE ARTHROSCOPY CASE ON (B)(6) 2024, THE INNER TUBE OF THE RASP WAS BROKEN INSIDE AND DETACHED. SINCE THE DAMAGED PART WAS INSIDE THE TUBE AND THE JOINT COULD NOT BE CONFIRMED, THE WOUND WAS CLOSED AFTER CONFIRMING THAT NO METAL FRAGMENTS REMAINED IN THE SURGICAL FIELD USING FLUOROSCOPY AND FLUOROSCOPY. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS OR DELAYS.

  Patient problems: Insufficient Information

  MAUDE report 18739404 ↗
• MalfunctionDec 15, 2023Defective Device; Defective Device

  ON 11/17/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8350PR POWERASP FAILED. THIS OCCURRED DURING A CASE ON 11/10/2023. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18340952 ↗
• MalfunctionSep 12, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8350PR POWERASP INNER CYLINDER BROKE OFF. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401830 ↗
• MalfunctionAug 31, 2021Loose or Intermittent Connection; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANKLE-ARTHROSCOPY, THE MOVEMENT OF THE RASP BECAME SLUGGISH AND THE INNER CYLINDER CAME OFF DURING DIRECT PATIENT INTERACTION. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 12393498 ↗
• MalfunctionApr 26, 2021Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPIC PROCEDURE, THE AR-8350PR, BROKE DURING USE. THE FRAGMENT REMAINS IN THE PATIENT. THE CASE WAS COMPLETED BY USING A NEW AR-8350PR.

  Patient problems: Foreign Body In Patient

  MAUDE report 11724416 ↗