NA 5450800305Recalls & reported problems
Stryker Corporation · Nakagawa Serrated Knife Tip, Universal · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252026662), received between Apr 1, 2019 and Apr 1, 2019 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE SHAVING OF A SPINAL CORD TUMOR, THE TIP BROKE AND THE DURA OF THE PATIENT WAS PERFORATED. THERE WAS NO DELAY OR MEDICAL INTERVENTION REPORTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO OTHER ADVERSE CONSEQUENCES REPORTED.
Patient problems: Perforation
MAUDE report 8470420 ↗
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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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