NA 702465Recalls & reported problems
Stryker GmbH · Double Drill Guide · Class 1
Data updated Oct 13, 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 04546540112163), received between Nov 19, 2018 and Nov 19, 2018 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2018Break; Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT THE CANNULATED DRILL IS STUCK INSIDE THE DRILL GUIDE. THE DRILL SNAPPED AS THE SURGEON WAS TRYING TO GET IT OUR OF THE GUIDE. NO PIECES FELL INTO THE PATIENT. 5 MINS SURGICAL DELAY WHILE A NEW SET WAS OPENED. NO ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8084098 ↗
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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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