Arthrex® AR-18700-54Recalls & reported problems
Arthrex, Inc. · Driver Shaft, T8, Self Retaining, AO · Class 1
Data updated Oct 18, 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 00888867316270), received between Jun 4, 2024 and Dec 8, 2025 — classified as 3 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
- Fitting Problem1
- Material Deformation1
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.
MalfunctionDec 8, 2025Break; Break
ON 11/19/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-18700-54 T8 SELF-RETAINING DRIVER SHAFT TIP BROKE OFF IN THE HEAD OF A 2.4 SCREW DURING A PROXIMAL PHALANX FRACTURE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744417 ↗MalfunctionFeb 5, 2025Material Deformation; Material Deformation
ON 01/13/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-18700-54 DRIVER SHAFT WAS WARPED. THIS OCCURRED DURING AN F&A RECONSTRUCTION ON (B)(6) 2025 THAT WAS COMPLETED USING A BACKUP DRIVER IN THE SET. THERE WAS NO DELAY IN THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 21314529 ↗MalfunctionJun 4, 2024Fitting Problem; Fitting Problem
ON 04/12/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-54 DRIVER SHAFT WOULD NOT MATE. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19457252 ↗
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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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