Arthrex® AR-8943-30Recalls & reported problems
Arthrex, Inc. · 2.5mm Drill Bit · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867052376), received between Sep 26, 2017 and Sep 26, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2017Material Fragmentation; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE OR STAFF REPORTED THAT DURING AN ANKLE FRACTURE PROCEDURE WHILE THE SURGEON WAS DRILLING INTO THE TIBIA; THE TIP BROKE OFF IN THE PATIENT'S TIBIA. THE SURGEON ATTEMPTED TO RETRIEVE THE TIP, BUT WAS UNSUCCESSFUL. THE TIP OF THE REAMER WAS LEFT IN THE PATIENT. PATIENT: (B)(6) MALE. CALLER DID NOT HAVE ANY ADDITIONAL DETAILS TO PROVIDE. FOLLOW-UP INVESTIGATION: PER THE SALES REP, THE BONE WAS REPORTED TO BE HARD AND THE SURGEON WAS APPLYING A LOT OF PRESSURE ON THE DRILL BIT AND IT BROKE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6893456 ↗
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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