NA 1806-6166Recalls & reported problems
Stryker GmbH · Crown Drill · 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 04546540510020), received between Feb 24, 2022 and Jun 18, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2024Naturally Worn; Naturally Worn
AS REPORTED: "CASE: REMOVAL OF METAL WORK (SYNTHES BLADE PLATE) WITH TIMEX KIT. REVISE USING ALPHA ANTEGRADE NAIL. IT WAS REPORTED THAT ALL THE CROWN DRILLS WERE BLUNT. ANOTHER COMPANY¿S KIT HAD TO BE OPENED TO REMOVE THE BROKEN SCREWS FROM THE BLADE PLATE. THE RECON DRILL AND SCREW WERE INSERTED INTO POSITION B, HOWEVER WHEN IT CAME TO POSITION A THE DRILL AND SCREW MISSED THE NAIL. THE SURGEON HAD TO DRILL AND ADVANCE THE SCREW FREE HAND WITHOUT THE USE OF THE TARGETING ARM. THE PROCEDURE LIKELY TOOK LONGER AND THE TEAM HAD TO OPEN SEVERAL ADDITIONAL KITS - ANOTHER COMPANY¿S SCREW REMOVAL KIT, ANOTHER COMPANY¿S CANNULATED DRILL KIT, AND STRYKER¿S ASNIS 6.5MM CANNULATED SCREW KIT. I WOULD ESTIMATE AROUND 20-30 MINUTES FOR THE TIMEX PORTION, AND 30-45 MINUTES FOR THE RECON SCREW."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563481 ↗MalfunctionFeb 24, 2022Material Fragmentation; Material Fragmentation
AS REPORTED: "DURING REMOVAL, THE SCREW STOPPED IN THE MIDDLE AND THE TIP OF THE EXTRACTOR BROKE OFF WHEN THE SURGEON KEPT TURNING IT. THE BONE AROUND THE SCREW WAS THEN DRILLED USING A CROWN DRILL AND THE SCREW WAS REMOVED. IN DOING SO, THE DRILL TIP MAY HAVE HIT THE SCREW AND CHIPPED IT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13595953 ↗
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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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