NA 03.133.103SRecalls & reported problems
Synthes GmbH · 2.5MM DRILL BIT QC 170MM STER 80MM CALIBRATION · 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 10886982277398), received between Oct 13, 2022 and Oct 2, 2023 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Failure to Cut1
- Material Deformation1
Patient problems
- Insufficient Information1
- 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.
MalfunctionOct 2, 2023Break; Material Deformation; Break; Material Deformation
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A RIGHT TIBIAL PLATEAU FRACTURE. AFTER INSERTING 2 SCREWS, THE SURGEON DRILLED TO THE CONTRALATERAL SIDE BY THE DRILL BIT USING A UNIVERSAL DRILL GUIDE. AT THAT TIME, THE DRILL BIT PENETRATED THE SKIN ON THE CONTRALATERAL SIDE, GOT ENTANGLED IN THE STOCKING NET, AND BROKE OFF ABOUT 5 MM OF THE TIP OF THE DRILL BIT. BOTH THE TIP OF THE BROKEN DRILL BIT AND THE DRILL BIT ITSELF WERE REMOVED FROM THE PATIENT¿S BODY, AND IT WAS CONFIRMED BY THE SURGEON THAT THERE WERE NO FRAGMENTS LEFT IN THE PATIENT¿S BODY. THE BROKEN DRILL BIT WAS DEFORMED AND COULD NOT BE REMOVED FROM THE UNIVERSAL DRILL GUIDE, SO THE DEFORMED PART WAS CUT OFF WITH A PIN CUTTER AND THE OPERATION CONTINUED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT QC 170MM STER 80MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 17855403 ↗MalfunctionOct 13, 2022Failure to Cut; Failure to Cut
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR PROXIMAL HUMERUS. THE DRILL BIT COULD NOT CUT AT ALL EVEN THOUGH IT WAS NEW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT WAS LISTED AS STABLE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A DRILL BIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15595172 ↗
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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