Arthrex® AR-8610TDC-03Recalls & reported problems
Arthrex, Inc. · STEPDRILL, FOR 2.5MM HCS, LENGTH 30MM · 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 00888867197145), received between Dec 7, 2021 and Jun 2, 2024 — 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.
Reports received per month
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.
MalfunctionJun 2, 2024Break; Break
IT WAS REPORTED THAT THE DISTAL END IS BROKEN OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. FURTHER QUESTIONS WILL BE ASKED. UPDATE FROM 04-MAY-2022. UNFORTUNATELY, THE PROCESS CAN NO LONGER BE RECONSTRUCTED BY THE CUSTOMER. THE TIME OF THE ERROR REMAINS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19444685 ↗MalfunctionDec 7, 2021Break
IT WAS REPORTED THE DRILL BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. 29-NOV-2021 UPDATE: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED EVENT OCCURRED DURING A SURGERY. 30-NOV-2021 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED ON (B)(6) 2021. IT WAS FURTHER REPORTED THAT THE HALLUX VALGUS - SCARF SURGERY COULD BE FINISHED SUCCESSFULLY WITH ANOTHER DEVICE WITH THE SAME PART NUMBER. THE SURGEON (B)(6)WAS ABLE TO RETRIEVE EVERYTHING OUT OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12954200 ↗
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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