NA 702804Recalls & reported problems
Stryker GmbH · Tap AO Fitting · Class 1
Data updated Oct 13, 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 04546540372192), received between Aug 12, 2025 and Aug 12, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE TAP TIP BROKE OFF AND COULD NOT BE REMOVED. THE PROCEDURE WAS TERMINATED WITH THE TAP TIP REMAINING IN THE PATIENT'S BONE. IN SAME PROCEDURE, THE DRILL BIT WAS BROKEN. ALL DEBRIS WERE REMOVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22788886 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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