Arthrex® AR-8730-36PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867045873), received between Sep 6, 2024 and Sep 6, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY FOR AN ANKLE FRACTURE AND SYNDESMOSIS REPAIR. DURING THE PROCEDURE, TWO AR-8730-36PT LOW PROFILE SCREW, TI, 3.0 MM X 36 MM, CANCELLOUS, PARTIALLY THREADED, AN AR-8827-18 LOW PROFILE SCREW, 2.7 X 18 MM, CORTEX, AN AR-8827-22 LOW PROFILE SCREW, 2.7 X 22 MM, CORTEX, AN AR-8973DS FIBULOCK IMPLANT SYSTEM, AN AR-8973L-38-180 ARTHREX FIBULOCK NAIL, 3.8 X 180 MM LEFT, AND AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL WERE IMPLANTED. POST-OPERATIVE, THE PATIENT STARTED TO EXPERIENCE PAIN. ON (B)(6) 2024, REVISION SURGERY WAS PERFORMED TO REMOVE ALL THE IMPLANTS EXCEPT FOR THE AR-8973L-38-180 ARTHREX FIBULOCK NAIL. DURING THE REMOVAL OF THE IMPLANTS, THE DISTAL END OF THE EXTRACTION TOOL OF AN AR-8973RK FIBULOCK REMOVAL KIT BROKE OFF AFTER ROUGHLY 8 MALLET STRIKES. ANOTHER AR-8973RK FIBULOCK REMOVAL KIT WAS OPENED, AND THE SAME THING OCCURRED. THE EXTRACTION TOOLS BROKE, BUT NO PIECES WERE IN THE PATIENT. THE SURGEON ELECTED TO CLOSE AND FINISH THE CASE WITH THE NAIL STILL IMPLANTED AND FELT CONFIDENT THAT THE REMOVE

  Patient problems: Pain

  MAUDE report 20156927 ↗
• InjurySep 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 8/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY FOR AN ANKLE FRACTURE AND SYNDESMOSIS REPAIR. DURING THE PROCEDURE, TWO AR-8730-36PT LOW PROFILE SCREW, TI, 3.0 MM X 36 MM, CANCELLOUS, PARTIALLY THREADED, AN AR-8827-18 LOW PROFILE SCREW, 2.7 X 18 MM, CORTEX, AN AR-8827-22 LOW PROFILE SCREW, 2.7 X 22 MM, CORTEX, AN AR-8973DS FIBULOCK IMPLANT SYSTEM, AN AR-8973L-38-180 ARTHREX FIBULOCK NAIL, 3.8 X 180 MM LEFT, AND AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL WERE IMPLANTED. POST-OPERATIVE, THE PATIENT STARTED TO EXPERIENCE PAIN. ON (B)(6) 2024, REVISION SURGERY WAS PERFORMED TO REMOVE ALL THE IMPLANTS EXCEPT FOR THE AR-8973L-38-180 ARTHREX FIBULOCK NAIL. DURING THE REMOVAL OF THE IMPLANTS, THE DISTAL END OF THE EXTRACTION TOOL OF AN AR-8973RK FIBULOCK REMOVAL KIT BROKE OFF AFTER ROUGHLY 8 MALLET STRIKES. ANOTHER AR-8973RK FIBULOCK REMOVAL KIT WAS OPENED, AND THE SAME THING OCCURRED. THE EXTRACTION TOOLS BROKE, BUT NO PIECES WERE IN THE PATIENT. THE SURGEON ELECTED TO CLOSE AND FINISH THE CASE WITH THE NAIL STILL IMPLANTED AND FELT CONFIDENT THAT THE REMOVED

  Patient problems: Pain

  MAUDE report 20156640 ↗