Formula 0375940000Recalls & reported problems
Stryker Corporation · [Aggressive 6-Flute Round Bur, Arthroscopic Shaver Blade, Do Not Resterilize, Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight] · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327054712), received between Mar 31, 2026 and Mar 31, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2026Material Fragmentation
IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, A FRACTION OF A BURR TIP FRACTURED AND REMAINED INSIDE THE PATIENT. DURING THE PATIENT'S FIRST POSTOPERATIVE VISIT AN X-RAY CONFIRMED THE FRAGMENT REMAINED IN THE PATIENT AND A FOLLOWUP SURGERY WAS PERFORMED TO REMOVE THE FRAGMENT.
Patient problems: Foreign Body In Patient
MAUDE report 24746562 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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