Arthrex® AR-8935-28Recalls & reported problems
Arthrex, Inc. · LO-PRO SCRW,TI,3.5MMX 28MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867050549), received between Sep 10, 2018 and Apr 17, 2023 — classified as 1 injury, 1 malfunction.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Foreign Body In Patient1
- Impaired Healing1
- Skin Inflammation1
- Swelling1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-8935-28 LOW PROFILE SCREWS HEAD BROKE OFF. THIS OCCURRED DURING A FIBULA FRACTURE ON (B)(6) 2023, WHEN THE HEAD STAYED ATTACHED TO THE SCREWDRIVER AFTER INSERTION INTO THE PROXIMAL PORTION OF THE PLATE. THE BODY OF THE SCREW REMAINS IMPLANTED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 16751992 ↗InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem
A PATIENT REPORTED THAT SHE UNDERWENT A PLANTAR LAPIDUS PROCEDURE ON HER RIGHT FOOT ON (B)(6) 2018. SINCE HER SURGERY PATIENT HAS BEEN EXPERIENCING WHAT SHE FEELS MAY BE POSSIBLE REACTION SYMPTOMS IN AND AROUND THE SURGICAL SITE WHICH INCLUDE: SLOW WOUND HEALING, REDNESS, ROUGH SKIN, SWELLING AND INFLAMMATION WHICH FLARES UP WORSE AT TIMES. PATIENT STATED THAT THERE IS NO INFECTION. PATIENT HAS PLANS TO GO TO AN ALLERGIST FOR ALLERGY TESTING TO THE MATERIALS WHICH COMPRISE HER ARTHREX IMPLANTS. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE (B)(6) 2018 SURGERY: AR-8941PR PLATE (QTY 1), AR-8935-24 CORTICAL SCREW (QTY 1), AR-8935-22 CORTICAL SCREW (QTY 1), AR-8935-28 CORTICAL SCREW (QTY 1) AND AR-8935-18 CORTICAL SCREW (QTY 2). DEVICES ARE TITANIUM AND PATIENT HAS BEEN PROVIDED THE MATERIAL COMPOSITION BREAKDOWN OF THE ASTM TITANIUM STANDARDS OF THE DEVICE MATERIAL.
Patient problems: Impaired Healing; Skin Inflammation; Swelling
MAUDE report 7861397 ↗
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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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