NA 03.130.310Recalls & reported problems
Synthes GmbH · 2.0MM DRILL BIT/K-WIRE ATTCHMT FOR GLIDING HOLE/71MM · Class 1
Data updated Oct 18, 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 10886982075604), received between Mar 19, 2026 and Mar 19, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (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
- 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.
MalfunctionMar 19, 2026Failure to Cut
IT WAS REPORTED THAT DRILL BIT Ø1.5 L88/57 F/CORE HOLE, 1.5 DRILL BIT/MQC FOR THREADED HOLE/74, 2.0 DB/K-WIRE ATTACHMENT GLIDING HOLE/71, AND DRILL BIT Ø2 L57/41 F/GLIDING HOLE WERE DULL AND NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY DURING SURGERY. THESE COMPONENTS WERE DEEMED NON-FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED, WITH REPLACEMENTS REQUIRED. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640273 ↗MalfunctionMar 19, 2026Failure to Cut
IT WAS REPORTED THAT DRILL BIT Ø1.5 L88/57 F/CORE HOLE, 1.5 DRILL BIT/MQC FOR THREADED HOLE/74, 2.0 DB/K-WIRE ATTCHMT GLIDING HOLE/71, AND DRILL BIT Ø2 L57/41 F/GLIDING HOLE WERE DULL AND NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY DURING SURGERY. THESE COMPONENTS WERE DEEMED NON-FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED, WITH REPLACEMENTS REQUIRED. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY OCCURRED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640247 ↗
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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