Arthrex® AR-8920DCRecalls & reported problems
Arthrex, Inc. · CANNULATED DRILL BIT, 3.5 MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867049000), received between Aug 5, 2024 and Aug 5, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 07/15/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-8963-21 LAG DRILL GUIDE HAD A DRILL BIT GET STUCK INSIDE THE TISSUE PROTECTOR GUIDE, WHICH SNAPPED WHEN TRYING TO REMOVE THE DRILL BIT (PHOTO ATTACHED). NO PIECES BROKE OFF INSIDE THE PATIENT. THE SURGEON STATED THAT THE TISSUE PROTECTOR GUIDE WAS WARPED, WHICH WAS WHAT CAUSED THE DRILL BIT TO GET STUCK IN THE FIRST PLACE. THE CASE WAS COMPLETED WITH NO FURTHER INFORMATION. THIS WAS DISCOVERED DURING AN OPEN REDUCTION INTERNAL FIXATION, TARSO METATARSAL JOINT DISLOCATION PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 7/16/2024: THERE WAS NO CASE DELAY REPORTED. THE CASE WAS COMPLETED WITHOUT AN ARTHREX PRODUCT AND COMPLETED BY FREEHAND. NO ADVERSE EFFECTS ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 08/01/2024: THE DRILL BIT PART NUMBER IS AR-8920DC CANNULATED DRILL BIT, 3.5 MM. IT COULD NOT BE REMOVED FROM THE SLEEVE OF THE AR-8963-21 LAG DRILL GUIDE AND IS STILL INSIDE THE DRILL LAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19905088 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page