NA 5400003111Recalls & reported problems
Stryker Corporation · Micro Dual Cut (9.0 x 0.38 x 25.0mm) · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540401816), received between Sep 24, 2020 and Jan 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2024Fracture; Fracture
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18556807 ↗MalfunctionSep 24, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION SURGERY, TWO BLADES BROKE AT THE PROXIMAL END OF THE BLADE, NO FRAGMENTS REMAINED AT THE SURGICAL SITE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A FIVE MINUTE DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BLADE THAT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10580211 ↗MalfunctionSep 24, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION SURGERY, TWO BLADES BROKE AT THE PROXIMAL END OF THE BLADE, NO FRAGMENTS REMAINED AT THE SURGICAL SITE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS A FIVE MINUTE DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.THIS REPORT IS FOR THE FIRST BLADE THAT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10580209 ↗
Other BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL devices
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- 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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