Arthrex® AR-300-B003Recalls & reported problems
Arthrex, Inc. · BURR, STRAIGHT 12 MM, DIA. 2.2 MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867099982), received between Jan 3, 2025 and Sep 10, 2025 — classified as 1 injury, 1 malfunction.
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
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.
MalfunctionSep 10, 2025Break; Break
ON 08/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO AR-300-B002 BURRS BROKE DURING USE IN THE CASE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23020044 ↗InjuryJan 3, 2025Break; Break
IT WAS REPORTED THAT DURING A MIS CALCANEUS OSTEOTOMY SURGERY THE DEVICE BROKE OFF WHILE DRILLING, WITHOUT LEVERAGE. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A FOREIGN SAWBLADE, THE SURGICAL TECHNIQUE HAD TO CHANGE TO AN OPEN CALCANEUS OSTEOTOMY. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.
Patient problems: Insufficient Information
MAUDE report 21069011 ↗
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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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