Medline 72200728RRecalls & reported problems
Medline Industries, Inc. · 72200728 @ELITE STONECTR BUR, (MAROON/YE · Class 2
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 10888277388550), received between May 6, 2019 and Sep 17, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Material Fragmentation3
- Dull, Blunt1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Break; Dull, Blunt
It was reported that "Doctor was using burr at highest speed and said he felt like it was not cutting the bone as efficiently as the OEM. Compared it to using a butter knife."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50804972 ↗MalfunctionMay 6, 2019Break; Material Fragmentation
IT WAS REPORTED THAT THE SURGICAL SITE REQUIRED IRRIGATION AFTER THE REPROCESSED DYONICS ELITE STONECUTTER BUR BROKE DURING USE AND ITS METAL SHAVINGS REACHED THE SURGICAL SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8583481 ↗MalfunctionMay 6, 2019Break; Material Fragmentation
IT WAS REPORTED THAT THE SURGICAL SITE REQUIRED IRRIGATION AFTER THE REPROCESSED DYONICS ELITE STONECUTTER BUR BROKE DURING USE AND ITS METAL SHAVINGS REACHED THE SURGICAL SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8583367 ↗MalfunctionMay 6, 2019Break; Material Fragmentation
IT WAS REPORTED THAT THE SURGICAL SITE REQUIRED IRRIGATION AFTER THE REPROCESSED DYONICS ELITE STONECUTTER BUR BROKE DURING USE AND ITS METAL SHAVINGS REACHED THE SURGICAL SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8583228 ↗
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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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