NA 4125119090Recalls & reported problems
Stryker Corporation · Dual Cut Sagittal Blade · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540964373), received between May 18, 2022 and Jul 22, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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
- Delivered as Unsterile Product1
- Fracture1
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.
MalfunctionJul 22, 2026Delivered as Unsterile Product
This record is a consolidation of records summarized as a part of the FDA Voluntary Malfunction Summary Reporting program.Events occurred between April 1 ¿ (b)(6) 2026.This report summarizes 0 events for the failure: Delivered as Unsterile Product.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25907841 ↗MalfunctionMay 18, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 14432874 ↗
Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices
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- 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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