Arthrex® AR-8935L-32SRecalls & reported problems
Arthrex, Inc. · LOW PROFILE LOCKING SCREW 3.5 MM X 32 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 00888867051041), received between Sep 27, 2023 and Sep 27, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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.
Most reported problems
Device problems
- Defective Device1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2023Defective Device; Defective Device
ON 8/29/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8935L-32S LOW PROFILE LOCKING SCREW WENT THROUGH THE PLATE AND DID NOT LOCK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING A NEW PRODUCT. ADDITIONAL INFORMATION RECEIVED ON 9/11/2023: THIS WAS DISCOVERED DURING A DISTAL FIBULAR FIXATION PROCEDURE AND COMPLETED USING ANOTHER AR-8935L-32S LOW PROFILE LOCKING SCREW. THE SCREW THAT WENT THROUGH THE PLATE REMAINED INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 17824966 ↗
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- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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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