Arthrex® AR-8973L-38-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867295261), received between Feb 15, 2019 and Oct 24, 2024 — 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.

• MalfunctionOct 24, 2024Failure to Advance; Failure to Advance

  ADDITIONAL INFORMATION RECEIVED ON 10/23/2024: THIS WAS DISCOVERED WHILE THE NAIL WAS ALREADY IN THE PATIENT. NOTHING BROKE OFF IN THE PATIENT. THE CASE WAS COMPLETED USING AN AR-8973L-30-180 ARTHREX FIBULOCK NAIL, A SMALLER NAIL. THE CASE WAS ONLY DELAYED LONG ENOUGH TO GET THE NAIL. ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522113 ↗
• 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 20156946 ↗
• InjuryFeb 15, 2019Break

  IT WAS REPORTED THAT DURING A ANKLE ARTHROSCOPY PROCEDURE, AFTER THE SURGEON ADVANCED THE FIBULA NAIL, AR-8973L-38-180, INTO THE DISTAL PORTION OF THE FIBULA, THE SURGEON HAD TO PULL THE NAIL BACK TO RE-ALIGN THE DISTAL PORTION WITH THE PROXIMAL PORTION OF THE FIBULA. WHEN HE RETRACTED THE NAIL BACK THE HEAD OF THE NAIL BROKE. THE CASE WAS COMPLETED BY PLATING AFTER THE INCIDENT. *ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 1/25/2019: THIS WAS A FIBULA FRACTURE REPAIR PROCEDURE. THE TIP OF THE NAIL BROKE BUT DID NOT DETACH FROM THE REST OF THE DEVICE; THEREFORE, NO FRAGMENTS REMAINED IN THE PATIENT. AN ADDITIONAL INCISION WAS CREATED FOR THE INSERTION OF THE PLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344553 ↗