NA 2351-6113Recalls & reported problems
Stryker GmbH · Opening Reamer · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327368161), received between May 31, 2024 and May 31, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Residue After Decontamination” (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. 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
- Residue After Decontamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 31, 2024Residue After Decontamination; Residue After Decontamination
AS REPORTED: "INSTRUMENT CLEANLINESS: A. AN UNKNOWN PIN ~3.2 X 290MM WAS FOUND INSIDE THE OPENING REAMER (2351-6113). IT WAS COMPLETELY EMBEDDED AND JAMMED INSIDE THE REAMER. THE PIN, ALONG WITH THE REAMER LUMEN, WERE COVERED WITH DRY BLOOD/ TISSUE AFTER MANUAL REMOVAL IN SSU. B. A LONG SCREWDRIVER 3.5MM (1806-0233) WAS INSIDE THE SCREWDRIVER SLEEVE (AS A 2-PART INSTRUMENT). WHEN THE 2 PARTS WERE SEPARATED, THE SCREWDRIVER SHAFT AND THE SCREWDRIVER SLEEVE'S LUMEN WERE ALSO COVERED WITH DRY BLOOD/ TISSUE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19435580 ↗
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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 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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