Arthrex® AR-8954-02Recalls & reported problems
Arthrex, Inc. · HANDLE, T, KEYLESS CHUCK CANNULATED · 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 00888867055247), received between Jun 6, 2024 and Jun 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 03/06/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AR-8954-02 T-HANDLE LOT: 78421725, BROKE IN HALF. THIS WAS DISCOVERED DURING USE IN A DURING A CALCANEAL FRACTURE REPAIR PROCEDURE ON (B)(6) 2022. THE SURGEON OPENED A SECOND 3.5/4.0 AND THE AR-8954-02 T HANDLE LOT:78421642 WAS LOCKED AND RUSTED. REQUESTED ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 19489505 ↗MalfunctionJun 6, 2024Break; Break
ON 03/06/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AR-8954-02 T-HANDLE LOT: 78421725, BROKE IN HALF. THIS WAS DISCOVERED DURING USE IN A DURING A CALCANEAL FRACTURE REPAIR PROCEDURE ON (B)(6) 2022. THE SURGEON OPENED A SECOND 3.5/4.0 AND THE AR-8954-02 T HANDLE LOT:78421642 WAS LOCKED AND RUSTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19478115 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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