Arthrex® AR-8970-03Recalls & reported problems
Arthrex, Inc. · T20 HEXALOBE DRIVER · Class 1
Data updated Oct 16, 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 00888867133747), received between Feb 3, 2026 and Feb 3, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt2
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.
MalfunctionFeb 3, 2026Dull, Blunt
IT WAS REPORTED THAT DURING A SURGERY THE SCREWDRIVERS WERE HEAVILY WORN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE 14-JAN-2026: THE REPORTED DEVICES ARRIVED AT ARTHREX GMBH AND DURING AN INITIAL INSPECTION OF THE DEVICES IT WAS NOTICES THAT THE TIP OF THE DEVICE AR-8970-03 (LOT: 1392436) IS BROKEN OFF. UPDATE 27-JAN-2026: IT WAS CONFIRMED THAT NO FRAGMENTS REMAINED INSIDE THE PATIENT AND THE DEVICE MIGHT HAVE BROKEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251575 ↗MalfunctionFeb 3, 2026Dull, Blunt
IT WAS REPORTED THAT DURING A SURGERY THE SCREWDRIVERS WERE HEAVILY WORN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251573 ↗
Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices
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- Arthrex® AR-13991NArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE128 reports
- Arthrex® AR-8981-08SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall3 reports
- Arthrex® AR-8981-06SArthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall1 report
- Centurion EB16Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- Medline Industries, Inc. DYNJ901391DMedline Industries, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 reports
- HarmonyAIR LAS0042Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 recall0 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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