Arthrex® AR-8835-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867047457), received between May 3, 2017 and Oct 9, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06676104 THAT AN AR-8835-45 LOW PROFILE SCREW HEAD OF THE ANKLE BOX BROKE OFF. THIS OCCURRED DURING A PROCEDURE THE DEVICE BROKE OFF INSIDE THE PATIENT'S FIBULA.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20410618 ↗
• InjuryMay 3, 2017Break

  IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW5068608): "PATIENT UNDERWENT A SURGICAL PROCEDURE IN 2016 OF ARTHROSCOPY LEFT KNEE AND OPEN MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION. DURING THE SURGERY AN IMPLANT DOCUMENTED AS ARTHREX NPFL IMPLANT SYSTEM WAS USED RELATED TO HER ANTERIOR TIBIAL TUBERCLEPLASTY AND PATELLOFEMORAL LIGAMENT RECONSTRUCTION WITH 2 SCREWS PLACED IN ORDER TO MAINTAIN THE GRAFT IN ITS MEDIAL POSITION. NO COMPLICATIONS WERE DOCUMENTED. IN 2017 DOCUMENTATION FROM THE ORTHOPEDIC SURGEON REVEALED THE PATIENT WAS IN FOR A FOLLOW UP AND WAS HAVING PAIN AND TENDERNESS RIGHT OVER HER TIBIAL TUBEROSITY TRANSFER. UPON X-RAY OF HER KNEE THE RESULTS REVEALED IN LATERAL VIEW SOME SLIGHT PROMINENCE OF ONE OF HER SCREWS THAT COULD CORRELATE WITH HER TENDERNESS. ON (B)(6) 2017 THE PATIENT PRESENTED TO THE HOSPITAL FOR SURGICAL PROCEDURE OF ARTHROSCOPY OF HER KNEE, SYNOVECTOMY AND REMOVAL OF DEEP IMPLANTS IN PROXIMAL TIBIA UNDER GENERAL ANESTHESIA. THE SURGEON DOCUMENTED THAT THE DISTAL MOST SCREW WAS IDENTIFIED BY PALPATION AND PATELLA TENDON SPLIT ALLOWED REMOVAL OF THAT SCREW WITHOUT DIFFICULTY. THE SECOND SCREW WAS IDENTIFIED MORE MEDIALLY AND ALSO REMOVED WITHOUT ANY DIF

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 6540725 ↗