NA 03.010.165Recalls & reported problems
Synthes GmbH · 15.0MM CANN FLEXIBLE DRILL BIT LARGE QC/310MM · Class 1
Data updated Oct 16, 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 10886982068002), received between Mar 16, 2021 and Sep 29, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
- Contamination /Decontamination Problem1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
ISSUE IDENTIFIED DURING STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15503842 ↗MalfunctionApr 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A PROCEDURE IT WAS NOTICED THAT THE SPIRAL DRILL GETS CAUGHT IN THE DRILL CHUCK. IT WAS VERY DIFFICULT TO INSERT AND EVEN MORE DIFFICULT TO REMOVE. THERE WAS NO DAMAGE OF THE DRILL. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) 15.0MM CANN FLEXIBLE DRILL BIT LARGE QC/310MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14017399 ↗MalfunctionMar 16, 2021Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE DRILL BIT WAS BROKEN WHILE INSERTION. THERE WAS NO FRAGMENT GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 15.0MM CANN FLEXIBLE DRILL BIT LARGE QC/310MM. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11494760 ↗
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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