Arthrex® AR-8935L-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867050877), received between Feb 7, 2019 and Jun 6, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ON 01/24/2023 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8935L-16 SCREW WOULD NOT LOCK INTO THE PLATE. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476678 ↗
• MalfunctionMay 13, 2024Use of Device Problem; Use of Device Problem

  ON 05/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8935L-16 LOCKING SCREW WOULD NOT THREAD INTO THE PLATE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296950 ↗
• InjuryJun 23, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE PRODUCT TEAM THAT A SALES REP HAS REPORTED A POSSIBLE PATIENT REACTION INCIDENT INVOLVING AN ARTHREX VOLAR PLATE. THE MATERIAL COMPOSITION INFORMATION WAS PROVIDED TO THE SALES REP, FOR THE SURGEON, BY THE PRODUCT TEAM. ADDITIONAL INFORMATION PROVIDED 6/1/2020: THE PATIENT HAD UNDERGONE A DISTAL RADIUS FRACTURE ORIF PROCEDURE ON (B)(6) 2020. THE PATIENT HAD THE INITIAL POST OP VISIT ON (B)(6) 2020 AT WHICH TIME THE PATIENT WAS TAKEN TO THE OR FOR AND IRRIGATION AND DEBRIDEMENT FOR A PRESUMED INFECTION. CULTURES HAS ALL BEEN NEGATIVE: NEGATIVE AEROBIC, ANAEROBIC, FUNGAL AND AFB. SYMPTOMS OF DRAINAGE, BLISTERING, RASHES AND WOUND HEALING ISSUES HAVE ALL BEEN ASSESSED BY THE SURGEON, INFECTIOUS DISEASE AND DERMATOLOGY. PATIENT HAS BEEN TREATED TO DATE WITH STEROIDS AND ANTIBIOTICS (TOPICAL AND ORAL). IT IS UNKNOWN IF PATIENT HAS BEEN TESTED FOR SPECIFIC KNOWN ALLERGIES HOWEVER IT HAS BEEN REPORTED THAT PATIENT HAS DEVELOPED ALLERGIC REACTION TO ALMOST EVERYTHING (ADHESIVE, SUTURE, PREP, MULTIPLE ANTIBIOTICS). THE PATIENT HAS AN ALLERGIST VISIT SCHEDULED FOR (B)(6) 2020. THE FOLLOWING ARE THE ARTHREX DEVICES THAT WERE IMPLANTED DURING THE (B)(6) 2020 PROCEDU

  Patient problems: Impaired Healing; Rash; Reaction; Swelling

  MAUDE report 10184227 ↗
• InjuryFeb 7, 2019Break

  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 8317065 ↗