Arthrex® AR-8935-16SRecalls & reported problems
Arthrex, Inc. · LOW PROFILE SCREW 3.5 MM X 16 MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867050433), received between Feb 7, 2019 and Feb 7, 2019 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2019Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DRIVER TIP BROKE OFF IN THE SCREW DURING REMOVAL OF A LAPIDUS PLATE. ADDITIONAL INFORMATION OBTAINED (B)(6) 2019: THE PATIENT¿S ORIGINAL IMPLANT CASE WAS A LAPIDUS PROCEDURE. THE EXPLANT PROCEDURE, WHICH WAS A REMOVAL OF A LAPIDUS PLATE AND SCREWS, TOOK PLACE ON (B)(6) 2019. DEVICES WERE BEING EXPLANTED DUE TO PATIENT PAIN. DATE OF ORIGINAL LAPIDUS SURGERY HAS NOT BEEN PROVIDED AT THIS TIME. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE (B)(6) 2019 PROCEDURE: AR-8941 LAPIDUS PLATE (QTY 1); AR-8935L-14 LOCKING SCREW, (QTY 1); AR-8935L-16 LOCKING SCREW (QTY 2); AND AR-8935-16 CORTICAL SCREW (QTY1). AFTER THE DRIVER TIP BROKE THE SURGEON CHOSE TO NOT EXPLANT THE 4.0 HEADLESS SCREW AND IT REMAINS IN THE PATIENT¿S BODY. NO FRAGMENTS OF THE BROKEN DRIVER WERE LEFT IN THE PATIENT.
Patient problems: Pain
MAUDE report 8317215 ↗
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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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