Arthrex® AR-8935-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867050440), received between Sep 5, 2018 and Jun 24, 2025 — classified as 2 injuries, 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Positioning Failure; Positioning Failure

  ON 3/31/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO 2.4 MM VAL SCREWS WENT THROUGH AN AR-8916VSR-05 VOLAR DISTAL RADIUS PLATE DURING INSERTION. THE ENTIRE CONSTRUCT HAD TO BE REMOVED IN ORDER TO CHANGE PLATES. THE PLATES WERE CHANGED TO A WIDE PLATE AND THE SURGEON RE-DRILLED AND RE-SIZED THE SCREWS. THIS WAS DISCOVERED DURING A DISTAL RADIUS FRACTURE PROCEDURE ON 4/15/2025, ADDITIONAL INFORMATION WAS RECEIVED ON 4/15/2025: NOTHING BROKE INSIDE THE PATIENT. THE CASE WAS SUCCESSFULLY COMPLETED WITH A NEW PLATE AND SCREWS. HOWEVER, THE PROCEDURE WAS DELAYED BY APPROXIMATELY FORTY-FIVE MINUTES, REQUIRING THE ADMINISTRATION OF ADDITIONAL ANESTHESIA. ADDITIONAL INFORMATION RECEIVED ON 6/3/2025: A TOTAL OF FIVE PRODUCTS WERE RECEIVED. AN AR-8916VSR-05 VOLAR DISTAL RADIUS PLATE, AN AR-8724V-20 LOW PROFILE VA LOCKING SCREW, AN AR-8724V-22 LOW PROFILE VA LOCKING SCREW, AN AR-8724V-28 LOW PROFILE VA LOCKING SCREW, AND AN AR-8935-18 LOW PROFILE NON-LOCKING SCREW.

  Patient problems: Insufficient Information

  MAUDE report 22318373 ↗
• InjurySep 10, 2018Patient-Device Incompatibility

  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: Erythema; Impaired Healing; Inflammation; Swelling

  MAUDE report 7861410 ↗
• InjurySep 5, 2018Break

  DURING REMOVAL OF SCREWS/HARDWARE POST LISFRANC HEALING - SCREWS WERE BROKEN. THE DEVICES INVOLVED WERE AS FOLLOWS: AR-8935L-26 QTY 1. AR-8935L-20 QTY2. AR-8935-18 QTY 1. ADDITIONAL INFORMATION OBTAINED 8/27/18: THE ORIGINAL LISFRANC PROCEDURE TOOK PLACE ON (B)(6) 2017. IT WAS DISCOVERED THAT THE SCREWS WERE BROKEN AND THE REVISION WAS SCHEDULED DUE TO PATIENT PAIN AND BROKEN HARDWARE. THE DATE OF THE REVISION PROCEDURE WAS (B)(6) 2018, DURING WHICH BROKEN SCREWS WERE EXPLANTED. BOTH ORIGINAL AND REVISION PROCEDURES WERE PERFORMED AT THE SAME FACILITY BY THE SAME SURGEON. IT IS UNKNOWN IF ALL ORIGINAL IMPLANTS WERE EXPLANTED DURING THE REVISION. RISK MANAGER COULD ONLY CONFIRM THAT THE REPORTED SCREWS WERE EXPLANTED.

  Patient problems: Pain

  MAUDE report 7846947 ↗