MicroFX OCD 234-200-200Recalls & reported problems
Stryker Corporation · MICROFX OCD UNIVERSAL DRILL (PKG STERILE) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327004090), received between Jun 19, 2018 and Feb 11, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Break” (11 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.
Reports received per month
Most reported problems
Device problems
- Break11
- Material Fragmentation5
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information5
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Material Fragmentation
IT WAS REPORTED THAT DURING THE HIP SCOPE PROCEDURE, THE TOP OF THE MICROFX OCD UNIVERSAL DRILL (DISPOSABLE) SNAPPED OFF IN THE PATIENT. THE PART WAS REMOVED USING GRASPERS, NO ADDITIONAL X-RAYS REQUIRED TO LOCATE THE PIECE. THE CASE WAS FINISHED SUCCESSFULLY BUT WAS 25 MINUTES LONGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317627 ↗MalfunctionOct 23, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DRILL BIT BROKE OFF AT THE END DURING DRILLING. ALL BROKEN FRAGMENTS HAVE BEEN SUCCESSFULLY REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373516 ↗MalfunctionFeb 26, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TIP OF THE DRILL BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472338 ↗MalfunctionJan 10, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE TIP OF THE DRILL BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21130635 ↗MalfunctionSep 26, 2022Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT THE TIP OF THE DRILL BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15485516 ↗MalfunctionJun 13, 2022Break
IT WAS REPORTED THAT THE DRILL BIT BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14676630 ↗MalfunctionJun 13, 2022Break
IT WAS REPORTED THAT THE DRILL BIT BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14676568 ↗MalfunctionOct 27, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12708238 ↗MalfunctionOct 27, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12708235 ↗MalfunctionOct 27, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12708233 ↗MalfunctionOct 27, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12708191 ↗MalfunctionFeb 2, 2021Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11268690 ↗MalfunctionNov 12, 2019Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THE TIP BROKE DURING THE PROCEDURE. THE PIECES WERE RETRIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9310305 ↗MalfunctionJun 21, 2018Break
IT WAS REPORTED THAT THE PRODUCT BROKE DURING USE. ALL BROKEN PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7627612 ↗MalfunctionJun 19, 2018Break
IT WAS REPORTED THAT THE DRILL BIT BROKE. ALL BROKEN PIECES WERE RETRIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7616938 ↗
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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