NA 0940023000Recalls & reported problems
Stryker Corporation · 2.5 inch (63.5mm) Ion Nitrided Cast Cutter Blade · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540132253), received between Jul 12, 2018 and Nov 13, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Excessive Heating1
- Fracture1
Patient problems
- Abrasion1
- Burn(s)1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2019Fracture; Fracture
IT WAS REPORTED VIA THE CUSTOMER THAT, THEY OBSERVED A BROKEN BLADE WITHIN THEIR INVENTORY. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT, NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9318736 ↗MalfunctionJun 11, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT FOLLOWING THE REMOVAL OF A CAST IT WAS OBSERVED THAT THE CUSTOMER WAS CUT OR BURNED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Abrasion
MAUDE report 8687208 ↗MalfunctionSep 5, 2018Excessive Heating; Excessive Heating
IT WAS REPORTED THAT FOLLOWING REMOVAL OF A CAST FROM A INFANTS ARM, BURN MARKS WERE OBSERVED ON THE PATIENTS ARM. IT WAS ALSO REPORTED THAT THE EVENT DID NOT CAUSE A DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Burn(s)
MAUDE report 7847431 ↗MalfunctionJul 12, 2018Break; Break
IT WAS REPORTED THAT DURING A REMOVAL OF A CAST, THE CAST CUTTER BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS SLIGHT DELAY TO THE CAST REMOVAL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7681296 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.