NA 3910-500-850Recalls & reported problems
Stryker Corporation · 5MM PROBE · Class 1
Data updated Oct 16, 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 04546540556103), received between May 20, 2019 and Feb 1, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2022Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13419312 ↗MalfunctionMay 20, 2019Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED, ALL PIECES WERE RETRIEVED AND THE NEED FOR AN EXPANDED PORTAL SIZE DOES NOT POSE ADDITIONAL RISK TO THE PATIENT AS IT IS WITHIN THE SCOPE OF THE ORIGINAL PROCEDURAL REQUIREMENTS TO CREATE A PORTAL LARGE ENOUGH TO PERFORM THE SURGERY AT THE DISCRETION OF THE SURGEON.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8625833 ↗
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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 13, 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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