NA 0296097102Recalls & reported problems
Stryker Corporation · Sternum Blade, Offset (31.5 x 0.64 x 6.2mm) · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 04546540895042), received between Jun 24, 2022 and Jul 22, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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. 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
- Fracture4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25908440 ↗MalfunctionApr 21, 2025Fracture; Fracture
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876063 ↗MalfunctionJan 12, 2023Fracture; Fracture
IT WAS REPORTED DURING A ROUTINE FIELD SERVICE MAINTENANCE VISIT, A BLADE BROKE DURING TESTING. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16150010 ↗MalfunctionJun 24, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE IN TWO PIECES. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14801515 ↗
Other BLADE, SAW, SURGICAL, CARDIOVASCULAR devices
- NA 0298097100Stryker Corporation · BLADE, SAW, SURGICAL, CARDIOVASCULAR8 reports
- Stryker Performance Series 6207097101Stryker Corporation · BLADE, SAW, SURGICAL, CARDIOVASCULAR3 reports
- NA 0298097104Stryker Corporation · BLADE, SAW, SURGICAL, CARDIOVASCULAR2 reports
- NA 0298097101Stryker Corporation · BLADE, SAW, SURGICAL, CARDIOVASCULAR2 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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