NA 03.133.101SRecalls & reported problems
Synthes GmbH · 2.0MM DRILL BIT QC 140MM STER 60MM 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 10886982277374), received between Jul 7, 2022 and Aug 29, 2022 — classified as 2 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 18, 2026.
Most reported problems
Device problems
- Break2
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.
MalfunctionAug 29, 2022Break; Break
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE ORIF SURGERY FOR DISTAL HUMERUS FRACTURE WITH THE VA-DHP. DURING THE PROCEDURE, THE DRILL BIT IN QUESTION WAS BROKEN WHILE DRILLING FOR LATERAL PLATE INSTALLATION AFTER MEDIAL PLATE IMPLANTATION. THE FRAGMENT OF THE BROKEN DRILL BIT WAS REMOVED BY THE SURGEON, NO FRAGMENTS WERE LEFT IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM DRILL BIT QC 140MM STER 60MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15311801 ↗MalfunctionJul 7, 2022Break; Break
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING ORIF SURGERY FOR FRACTURE OF DISTAL END OF HUMERUS, THE DRILL BIT BROKE WHILE DRILLING. THE SURGEON COMMENTED THAT THEY USED IT IN A BOWING STATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A 2.0MM DRILL BIT QC 140MM STER 60MM CALIBRATION. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14949469 ↗
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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