ICONIX 3910-500-568Recalls & reported problems
Stryker Corporation · 1.4MM ICONIX DISPOSABLE DRILL · Class 1
All models of ICONIX (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252450498), received between Jul 15, 2019 and Aug 30, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Break2
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2022Break
IT WAS REPORTED THAT THE TIP OF THE DRILL BROKE OFF AND REMAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15322748 ↗MalfunctionAug 18, 2022Break
IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15252549 ↗MalfunctionJul 15, 2019Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS DEBRIS IN THE JOINT. THE DEBRIS WAS FLUSHED OUT OF THE JOINT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8789528 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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