Formula 0375940012Recalls & reported problems
Stryker Corporation · [Standard 12-Flute Round Bur, Arthroscopic Shaver Blade, Do Not Resterilize, Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight] · Class 1
All models of Formula (43)
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 07613327054729), received between Nov 1, 2018 and May 6, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Device Contaminated During Manufacture or Shipping1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE HOOD OF BUR WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21971931 ↗MalfunctionAug 28, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17633897 ↗MalfunctionNov 1, 2018Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE REMOVED SUCCESSFULLY.
Patient problems: No Information
MAUDE report 8030871 ↗MalfunctionNov 1, 2018Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE REMOVED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8030867 ↗MalfunctionNov 1, 2018Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. ALL PIECES WERE REMOVED SUCCESSFULLY.
Patient problems: No Information
MAUDE report 8030863 ↗
Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices
- NA 511.801Synthes GmbH · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL223 reports
- Formula 0375544000Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL98 reports
- NA 0277096325Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL95 reports
- NA 310.25Synthes GmbH · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL91 reports
- Arthrex® AR-8400TDArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL86 reports
- NA 0277096275Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL72 reports
- Arthrex® AR-7300DSArthrex, Inc. · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL70 reports
- NA 0277096277Stryker Corporation · BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL69 reports
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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