NA 03.133.106Recalls & reported problems
Synthes GmbH · 2.8MM DRILL BIT QC 135MM 45MM CALIBRATION · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982269652), received between Nov 13, 2025 and Nov 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Failure to Cut2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2025Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility
IT WAS REPORTED DURING THE SURGERY, THE USF 1 CONSIGNMENT EQUIPMENT WAS USED AND WHEN THE DOCTOR ASKED FOR THE DRILL BITS TO FIX THE PLATE, THEY WERE VERY DIFFICULT TO ENTER THE PATIENT'S BONE, REQUESTING A CHANGE OF DRILL BIT. WITH EACH DRILL BIT THAT HE PASSED, THE SAME PROBLEM OCCURRED, CAUSING A DELAY. THE SURGERY WAS CARRIED OUT. IT ENDED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543076 ↗MalfunctionNov 13, 2025Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility
IT WAS REPORTED DURING THE SURGERY, THE USF 1 CONSIGNMENT EQUIPMENT WAS USED AND WHEN THE DOCTOR ASKED FOR THE DRILL BITS TO FIX THE PLATE, THEY WERE VERY DIFFICULT TO ENTER THE PATIENT'S BONE, REQUESTING A CHANGE OF DRILL BIT. WITH EACH DRILL BIT THAT HE PASSED, THE SAME PROBLEM OCCURRED, CAUSING A DELAY. THE SURGERY WAS CARRIED OUT. IT ENDED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23543071 ↗
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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