Arthrex® AR-9350PRRecalls & reported problems
Arthrex, Inc. · POWERASP, SMALL HUB, 3.5MM X 7 CM · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867251953), received between Apr 17, 2023 and Jun 13, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Overheating of Device1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE HANDPIECE BECAME HOT WHEN USED WITH AN AR-9350PR AND THE AR-8305 CONSOLE REPORTED A CRITICAL ERROR. THE CONSOLE WAS TURNED OFF THEN ON AGAIN AND THE POWER RASP DID NOT WORK.
Patient problems: Insufficient Information
MAUDE report 19534165 ↗MalfunctionApr 17, 2023Break; Break
ON 3/17/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-9350PR POWERASP TIP BROKE OFF DURING USE. A DIFFERENT KIND OF SHAVER AND A ROUND BAR WERE USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16751271 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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