Arthrex® AR-9091-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867335301), received between Mar 28, 2024 and Jul 25, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 06/30/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9091-02 HINDFOOT NAIL CABLE TENSIONER CABLE SETTING SCREWS IN THE TENSIONER HAVE BEEN REVERSE THREADED INTO THE JIG AND FREQUENTLY GETS STUCK. THIS HAPPENED DURING A CASE AND HAD NO ADVERSE EFFECTS ON THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED VIA PHONE, WHERE THE SALES REPRESENTATIVE STATED THIS EVENT OCCURRED DURING AN ANKLE FUSION PROCEDURE ON (B)(6) 2025, WHERE THEY WERE UNABLE TO COMPRESS THE NAIL. THIS RESULTED IN A DELAY OF ABOUT 15-20 MINUTES THAT DID NOT REQUIRE ADDITIONAL ANESTHESIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608001 ↗
• InjuryJan 6, 2025Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  ON 12/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ARTHREX LOANER TRAY WAS RECEIVED A COUPLE OF DAYS BEFORE THE SURGERY TOOK PLACE ON (B)(6) 2024. IT WAS VERIFIED THAT THE 9091-02 HINDFOOT NAIL CABLE TENSIONER WAS IN A ZEROED-OUT POSITION BEFORE BEING STERILIZED. ABOUT THIRTY MINUTES BEFORE THE SURGERY, IT WAS VERIFIED AGAIN THAT THE 9091-02 HINDFOOT NAIL CABLE TENSIONER WAS IN A ZEROED-OUT POSITION. DURING THE PROCEDURE, WHEN THE TECHNICIAN WENT TO TIGHTEN DOWN THE SET SCREW WITH THE HEX DRIVER, THE DRIVER IMMEDIATELY BEGAN TORQUING WITHOUT ACTUALLY TIGHTENING THE SCREW ITSELF. THE TECHNICIAN TRIED TO LOOSEN THE SET SCREW, BUT IT WAS PROVING VERY DIFFICULT TO LEFTY LOOSEY THE SCREW EVEN AFTER THE FIRST COUPLE OF TURNS. IT WAS ATTEMPTED AGAIN TO TIGHTEN THE SCREW DOWN AGAIN NOW, AND IT IMMEDIATELY CLICKED DUE TO THE TORQUE LIMITING FEATURE ON THE HEX DRIVER LIKE LAST TIME. THE CABLE TENSIONER WAS ALSO ABLE TO BE PULLED FREELY ON THAT SIDE DESPITE THE TORQUE LIMITER CLICKING LIKE IT WAS FULLY SEATED. THE OTHER SIDE WAS ATTEMPTED TO BE TIGHTENED, BUT THE SAME ISSUE WAS HAPPENING. AFTER ABOUT FIVE MINUTES, THE SURGEON NOTICED THE SET SCREWS WERE VERY ELEVATED AN

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

  MAUDE report 21079015 ↗
• InjuryOct 31, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/15/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-06686918 THAT AN AR-9091-02 HINDFOOT NAIL CABLE TENSIONER FAILED DURING A CASE. THE REP STATED THAT THE PATIENT WAS AFFECTED BY THE FAILURE. THEY COULD NOT USE THE NAIL'S TENSIONING COMPONENT AND HAD TO ADD ADDITIONAL HARDWARE TO COMPENSATE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 10/21/2024: THIS WAS DISCOVERED DURING A TTC NAIL PROCEDURE ON 10/14/2024. IT WAS STATED THAT THE FAILURE OF THE AR-9091-02 HINDFOOT NAIL CABLE TENSIONER WAS DUE TO THE SET SCREWS NOT MOVING UP AND DOWN WITHIN THE TENSIONER. THE SCREWS THEN ENDED UP SHEARING THE INNER WALL OF THE TENSIONER. THE SCREWS MAY HAVE ALSO BEEN STRIPPED. THE TENSIONER COULD NOT PULL THE NITINOL CORE OF THE NAIL TO GAIN COMPRESSION. THIS LEFT THE NAIL STATIC AND UNABLE TO USE THE SECOND CALCANEUS SCREW. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ADDITIONAL FIXATION OUTSIDE OF THE NAIL. THE TECHNIQUE WAS CHANGED DUE TO NOT BEING ABLE TO USE THE COMPRESSION FEATURE OF THE NAIL, AND AN UNPLANNED INCISION OCCURRED WITH THE SURGEON USING OUTSIDE SCREWS TO GET THE COMPRESSION ACROSS THE ANKLE JOINT. THE CASE WAS COMPLETED USING ARTHREX 7.0 H

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

  MAUDE report 20577676 ↗
• InjuryOct 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9091-02 HINDFOOT NAIL CABLE TENSIONER WOULD NOT RELEASE. THIS OCCURRED DURING A TTC FUSION ON (B)(6)2024 WHEN THE CABLES TENSIONER FOR THE TTC DUAL COMPRESSION NAIL WOULD NOT RELEASE AND SEEMED TO BE COLD WELDED. THEY WERE UNABLE TO USE THE DEVICE THE CORRECT WAY TO GAIN COMPRESSION. ONLY TWO SCREWS WERE IMPLANTED IN THE IM NAIL AND AUGMENTED WITH STAPLES TO ADD IN COMPRESSION. NAIL IS BEING REVISED AT A LATER DATE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 20461235 ↗
• MalfunctionMar 28, 2024Material Deformation; Material Deformation

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9091-02 HINDFOOT NAIL CABLE TENSIONER SCREW IS STRIPPED. IT WAS HARD TO TIGHTEN AND LOOSEN. WAS DAMAGED WHEN PUTTING IT ON THE JIG. AS SOON AS IT WAS PLACED ON THE JIG IT POPPED OFF. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997293 ↗