Arthrex® AR-8935L-30SRecalls & reported problems
Arthrex, Inc. · LOW PROFILE LOCKING SCREW 3.5 MM X 30 MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867051027), received between Mar 14, 2024 and Mar 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
- Unintended Movement1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2024Positioning Failure; Unintended Movement; Positioning Failure; Unintended Movement
ON 03/01/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA E-MAIL THAT AN AR-8935L-30S LOW PROFILE LOCKING SCREW WAS NOT ENGAGING THE LOCKING HOLE OF THE PLATE AND WAS SPINNING. THIS OCCURRED DURING THE CONTEMPLATIVE REPAIR AND FIXATION PROCEDURE USING A CALCANEAL FRACTURE PLATE (AR-8954YL-SS). DRILLING WAS PERFORMED USING AN AR-8935GV (VARIABLE DRILL GUIDE) AND AN AR-8943-42 (2.5 MM DRILL) AND A PLATE FIXATION SCREW WHEN THE SCREW WAS NOT ENGAGING THE LOCKING HOLE OF THE PLATE AND WAS SPINNING. THEY REPLACED THE SCREW AND USED AN AR-8935L-28S TO COMPLETE THE CASE, WHICH WAS IMPLANTED WITHOUT ANY PROBLEM.
Patient problems: Insufficient Information
MAUDE report 18906173 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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