Arthrex® AR-1409Recalls & reported problems
Arthrex, Inc. · HEADED REAMER 9MM, CANNULATED · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867016743), received between Jun 7, 2024 and Oct 15, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (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.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt2
- Break1
- Fitting Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Break; Break
ON 10/08/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1409 9MM CANNULATED-HEADED REAMER DRILL GUIDE BROKE DURING FEMORAL DRILLING FOR A KNEE LIGAMENT RECONSTRUCTION. NO FRAGMENTS WERE LEFT IN THE PATIENT, AND THE BONE QUALITY WAS GOOD FOR A YOUNG, UNAFFECTED PATIENT.
Patient problems: Insufficient Information
MAUDE report 23300481 ↗MalfunctionJun 20, 2025Dull, Blunt; Dull, Blunt
ON 3RD JUNE 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1409, CANNULATED HEADED REAMER, 9 MM, WAS BLUNT. THIS WAS DETECTED DURING USE IN AN ACL PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY OPENED A SINGLE USE SHARP REAMER.
Patient problems: Insufficient Information
MAUDE report 22296517 ↗MalfunctionJun 18, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE AR-1409 IS BLUNT. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563586 ↗MalfunctionJun 7, 2024Fitting Problem; Fitting Problem
IT WAS REPORTED THAT DURING A KNEE SURGERY THE PIN GOT STUCK IN THE CANNULATED DRILL BIT. 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 19483296 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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