Arthrex® AR-8943-08Recalls & reported problems
Arthrex, Inc. · SCREWDRIVER, T10 HEXALOBE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867052185), received between Sep 14, 2021 and Feb 6, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Break
ON 16-JAN-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8943-08 T10 HEXALOBE SCREWDRIVER TIP BROKE DURING A HARDWARE REMOVAL CASE. THE TIP THAT BROKE WAS NOT RECOVERED. X-RAYS WERE TAKEN TO ENSURE IT WAS NOT LEFT IN THE PATIENT. THE DRIVER WAS REPLACED, AND THE CASE CONTINUED WITH NO ADVERSE EFFECTS TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 20-JAN-2026. THE REP ADVISED THAT NO ATTACHMENT OR ADAPTER WAS USED, AND THAT THE 3.5 MM HEADLESS COMPRESSION SCREW WAS BEING REMOVED BY HAND VIA THE AR-8943-08.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24277856 ↗MalfunctionDec 6, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8770-01 DRIVER SHAFT, AND A AR-8943-08 SCREWDRIVER BROKE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15923867 ↗MalfunctionSep 14, 2021Break
IT WAS REPORTED THE DOCTOR WAS TIGHTENING A 2.7 SCREW IN DISTAL FIBULA PLATE AND ON THE LAST QUARTER TURN THE DRIVER TIP BROKE IN THE SCREW HEAD. THE DOCTOR WAS ABLE TO REMOVE THE BROKE PART FROM THE SCREW WITH NO ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 12466904 ↗
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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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