Arthrex® AR-8935-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867050488), received between Sep 10, 2018 and Sep 5, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• InjurySep 5, 2024Break; Break

  ON 8/12/2024, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT A CANCELLOUS COMPRESSION SCREW, BEING USED WITH A TROCAR TIP TO STABILIZE A LISFRANC INJURY, BROKE OFF IN THE FOOT. THE BROKEN FRAGMENTS WERE NOT REMOVED. ON (B)(6) 2024, THE PATIENT REPORTED THAT THE PROCEDURE TOOK PLACE ON (B)(6) 2024 IN WHICH AN AR-8935CL-26 KREULOCK COMPRESSION SCREW, AN AR-8935-22 NON-LOCKING LOW PROFILE SCREW, AN AR-8935CL-32 KREULOCK COMPRESSION SCREW, AND AN AR-8951MR MEDIUM RIGHT LISFRANC PLATE WAS IMPLANTED. ADDITIONALLY, ANOTHER PLATE AND 5 SCREWS WITH UNKNOWN PART NUMBERS WERE ALSO IMPLANTED. DURING THE PROCEDURE, ONE OF THE SCREWS BROKE ABOUT THE FIFTH THREAD DOWN. AT THIS TIME, IT IS UNKNOWN WHICH SCREW BROKE. THE SURGEON DECIDED TO LEAVE THE BROKEN FRAGMENT IN THE PATIENT, AS REMOVING IT WOULD CAUSE MORE HARM. ONCE THE PATIENT WAS HEALED, ON (B)(6) 2024, A SECOND PROCEDURE WAS PERFORMED TO REMOVE BOTH PLATES AND EIGHT SCREWS, EXCEPT THE BODY OF THE PREVIOUSLY BROKEN SCREW. THE PART NUMBER FOR THE TROCAR TIP REMAINS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20146596 ↗
• MalfunctionMar 24, 2023Break; Break

  ON 3/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935-22 LOW PROFILE SCREW HEAD BROKE DURING INSERTION. THE BODY OF THE SCREW WAS IDEALLY IMPLANTED AND WAS USED TO COMPLETE THE CASE. THE HEAD OF THE SCREW WAS REMOVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A FIBULAR FRACTURE PROCEDURE ON (B)(6) 2023.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16608957 ↗
• 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 7861380 ↗