NA 234-020-023Recalls & reported problems
Stryker Corporation · 3/32" X 12" FEMORAL EYELOOP DRILL (QTY 6) · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540755414), received between Apr 12, 2024 and Jul 3, 2024 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. 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 Fragmentation4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE ABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19667667 ↗InjuryApr 16, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING PATELLA FIXATION PROCEDURE, TWO FEMORAL EYE-LOOP DRILLS WERE USED AND SNAPPED INSIDE THE PATELLA. THE PORTION OF EACH DRILL REMAINING IN THE PATELLA WERE UNABLE TO BE RETRIEVED. THE PINS WERE FIRMLY LODGED, BUT AN XRAY WAS PERFORMED TO ASSESS WHETHER THE METAL WOULD IMPINGE ON THE SOFT-TISSUE OR DISCOMFORT. IT WAS DETERMINED THAT THE REMAINING PINS WOULD NOT CAUSE ANY FURTHER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19122159 ↗InjuryApr 16, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING PATELLA FIXATION PROCEDURE, TWO FEMORAL EYE-LOOP DRILLS WERE USED AND SNAPPED INSIDE THE PATELLA. THE PORTION OF EACH DRILL REMAINING IN THE PATELLA WERE UNABLE TO BE RETRIEVED. THE PINS WERE FIRMLY LODGED, BUT AN XRAY WAS PERFORMED TO ASSESS WHETHER THE METAL WOULD IMPINGE ON THE SOFT-TISSUE OR DISCOMFORT. IT WAS DETERMINED THAT THE REMAINING PINS WOULD NOT CAUSE ANY FURTHER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19122158 ↗InjuryApr 12, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THERE WAS AN INCIDENT WHERE THE PRODUCT HAS SNAPPED DURING AN OPERATION. THE BROKEN PIECES WERE POTENTIALLY UNABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19097419 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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