Arthrex® AR-611-11Recalls & reported problems
Arthrex, Inc. · iBal UKA, Femoral Peg Drill, Dia. 260 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867223905), received between Feb 14, 2022 and Jan 9, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation2
- Dull, Blunt1
- Flaked1
- Naturally Worn1
Patient problems
- Insufficient Information3
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Material Fragmentation; Material Fragmentation
ON 06/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-611-10 TIBIA PEG DRILL AND AR-611-11 FEMORAL PEG DRILL ARE WORN AND PIECES ARE STARTING TO SHAVE OFF. THIS WAS DISCOVERED DURING A CASE AND PRODUCED DEBRIS.
Patient problems: Foreign Body In Patient
MAUDE report 21111635 ↗MalfunctionJun 6, 2024Dull, Blunt; Dull, Blunt
ON 12/19/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-611-11 FEMORAL PEG DRILL DIA 0.260, AND A AR-611-10 TIBIAL PEG DRILL ARE DULL. THIS WAS DISCOVERED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19476750 ↗MalfunctionMay 9, 2024Naturally Worn; Naturally Worn
ON 11/17/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-611-11 PEG DRILL IS WORN. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON 11/17/2021. THE CASE WAS COMPLETED BY SWAPPING OUT THE CAMERA HEAD.
Patient problems: Insufficient Information
MAUDE report 19280115 ↗MalfunctionJul 28, 2023Material Fragmentation; Material Fragmentation
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-611-10 TIBIA PEG DRILL AND AR-611-11 FEMORAL PEG DRILL ARE WORN AND PIECES ARE STARTING TO SHAVE OFF. THIS WAS DISCOVERED DURING A CASE AND PRODUCED DEBRIS.
Patient problems: Insufficient Information
MAUDE report 17413921 ↗MalfunctionFeb 14, 2022Flaked
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-611-11 FEMORAL PEG DRILL WAS CREATING FLAKY METAL. THIS WAS DISCOVERED DURING A UKA SPORTSPLASTY PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 13529242 ↗
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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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