NA 03.130.112Recalls & reported problems
Synthes GmbH · 1.3MM DRILL BIT/MQC FOR GLIDING HOLE/46MM · 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 10886982075260), received between Apr 7, 2023 and Mar 18, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Failure to Cut1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2026Failure to Cut
DURING SURGERY, IT WAS NOTED THAT THE IDENTIFIED DRILL BITS LISTED IN THIS COMPLAINT WERE DULL AND WERE NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY. THESE COMPONENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. REPLACEMENTS ARE REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630135 ↗MalfunctionAug 20, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE TWO BITS BROKE. THIS REPORT INVOLVES ONE (1) 1.3MM DRILL BIT/MQC FOR GLIDING HOLE/46MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 20005424 ↗MalfunctionApr 7, 2023Break; Break
DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE DRILL BIT BREAKS WHEN DRILLING INTO BONE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø1.3 L46/29 F/GLIDING HOLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16702945 ↗
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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