NA 03.010.061SRecalls & reported problems
Synthes GmbH · 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIB-STERILE · 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 10886982067340), received between Apr 26, 2021 and Jan 27, 2026 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device-Device Incompatibility1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Break; Entrapment of Device
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DRILL BIT. WHEN THE SURGEON WAS TRYING TO LOCK THE DISTAL STENT, HE PRESSED THE DEVICE TOO HARD, CAUSING INTERFERENCE WITH THE NAIL. THE SURGEON USED A HAMMER TO KNOCK THE DEVICE THROUGH THE NAIL HOLE. AFTER CONNECTING THE DRILL TO THE POWER TOOL AND STARTING DRILLING, THE TIP OF DRILL BIT BROKE. THE DRILL TIP REMAINED INSIDE THE BODY, SO IT WAS EXCAVATED FROM THE PROXIMAL CORTICAL BONE AND REMOVED. AFTER THAT, THE SURGEON DRILLED FREEHAND AND INSERTED THE LOCKING SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. THE SURGEON COMMENTED THAT THE CORTICAL BONE WAS THICK, SO IT SEEMS THAT UNUSUAL STRESS WAS GENERATED IN THE DRILL BIT, CAUSING IT TO BREAK. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 24189124 ↗MalfunctionApr 26, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021 WHILE DRILLING FOR THE DISTAL SCREW OF A RETROGRADE/ANTEGRADE FEMORAL NAIL, THROUGH THE SPIRAL BLADE ATTACHMENT, THE DRILL BIT AND SCREW BOTH SKIVED POSTERIORLY MISSING THE NAIL ALL TOGETHER. THE SCREW WAS ABORTED AND THE SPIRAL BLADE WAS COMPLETED WITHOUT INCIDENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIB-STERILE. THIS IS REPORT 8 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726972 ↗
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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