NA 03.226.042Recalls & reported problems
Synthes GmbH · 4.0MM CANNULATED DRILL BIT · Class 1
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 10886982077189), received between Mar 31, 2022 and Nov 11, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem2
- Break1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE DAY BEFORE THE SURGERY, THE OPERATING ROOM POINTED OUT THAT A TOTAL OF EIGHT ITEMS IN FIVE INSTRUMENT SETS HAD NOT BEEN PROPERLY CLEANED WHEN THEY DELIVERED. ALL THE IMPACTED PRODUCTS OF THE HOLLOW PARTS WERE DIRTY AND APPEARED TO BE BLOOD STAINS. WHEN A BRUSH WAS PASSED THROUGH THE HOLLOW PARTS IN THE OPERATING ROOM, THE BRUSH WAS FOUND TO BE DIRTY, AND SOME INSTRUMENTS WERE SO CLOGGED THAT A BRUSH COULD NOT BE PASSED THROUGH. THE SALES REP ORDERED NEW INSTRUMENTS, HOWEVER MANY OF THEM HAD DROPS OF WATER IN THE HOLLOW PART. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525835 ↗MalfunctionJul 22, 2024Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2024, THE PROXIMAL TIBIA SCREWDRIVER OF 3.5 WAS DAMAGED DURING SURGERY, JUST LIKE THE PERFORATION DRILL BIT PREVIOUS. THE THREADED GUIDES ARE STUCK IN THE BONE, AND COULD NOT BE REMOVED. THIS REPORT INVOLVES ONE (1)4.0MM CANNULATED DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 19797776 ↗MalfunctionMar 31, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY. BEFORE SURGERY, AN OPERATION STAFF CHECKED THE PRODUCTS IN QUESTION AND FOUND THAT THERE WERE DIRT/WATER DROPS-LIKE-RESIDUES IN THE HOLLOW PART OF EACH PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13958646 ↗
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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