NA 4111119090Recalls & reported problems
Stryker Corporation · Dual Cut Sagittal Blade · Class 1
Data updated Oct 16, 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 04546540963291), received between May 23, 2024 and May 23, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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. 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
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A POST OPERATIVE X-RAY, A FOREIGN BODY REMAINED IN THE KNEE JOINT, A MINOR REVISION SURGERY WAS PERFORMED TO REMOVE THE FOREIGN BODY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19382214 ↗
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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