Arthrex® AR-1411LPRecalls & reported problems
Arthrex, Inc. · REAMER, LOW PROFILE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867016880), received between Jan 23, 2023 and Jul 10, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2024Break; Break
ON 6/14/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT AN AR-1411LP LOW PROFILE REAMER HAD ONE OF THE WINGS BREAK OFF DURING TIBIAL DRILLING. THE SURGEON WAS UNABLE TO IDENTIFY THE EXACT MOMENT OF BREAKAGE, BUT IT WAS NOTICED WHEN PULLED OUT, AND THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN FRAGMENT WITH NO ISSUES. THIS WAS DISCOVERED DURING THE LEFT KNEE ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/18/2024: THERE WAS A 9 MINUTE DELAY IN THE CASE WITH NO ADDITIONAL ANESTHESIA ADMINISTERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19710115 ↗MalfunctionJan 12, 2024Material Fragmentation; Material Fragmentation
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1411LP LOW PROFILE REAMERS FLUTES BROKE OFF. THIS OCCURRED DURING A PROCEDURE ON (B)(6) 2023 WHILE DRILLING THE FEMORAL SOCKET IN A STANDARD FASHION, THE FLUTES BROKE OFF. THE BROKEN FRAGMENTS WERE RETRIEVED FROM THE JOINT AND THE PATIENT WAS UNAFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502067 ↗MalfunctionJan 23, 2023Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1411LP LOW PROFILE REAMER BROKE. THIS WAS DISCOVERED DURING A PROCEDURE IN DECEMBER. NO FURTHER INFORMATION WAS GIVEN AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16223154 ↗
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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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