ICONIX 3910-500-573Recalls & reported problems
Stryker Corporation · 2.3MM ICONIX REUSABLE STRAIGHT DRILL · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252598718), received between May 13, 2019 and Feb 21, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DRILL BROKE DURING THE PROCEDURE. THE BROKEN PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21435449 ↗MalfunctionMar 9, 2022Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRILL BROKE DURING THE PROCEDURE AND REMAINED IN THE GUIDE. PLEASE NOTE, PER (B)(4), THIS REUSABLE DRILL IS ONLY COMPATIBLE WITH THE ICONIX STRAIGHT GUIDES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13714790 ↗MalfunctionJan 7, 2022Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13192572 ↗MalfunctionJan 9, 2020Break
IT WAS REPORTED THAT THE DEVICE BROKE AND PIECES POTENTIALLY REMAIN IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9570058 ↗MalfunctionMay 13, 2019Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. NO PIECES FELL INTO THE JOINT SPACE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8606223 ↗
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 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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