Arthrex® AR-9091-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867335295), received between Jul 12, 2024 and May 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Break

  ON 8-MAY-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9091-01 HINDFOOT TARGETING GUIDE BROKE DURING A CASE. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25332127 ↗
• MalfunctionMar 17, 2026Material Twisted/Bent

  ON (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9091-01 HINDFOOT NAIL TARGETING GUIDE WAS NOT ALIGNING CORRECTLY FOR THE PROXIMAL CALCANEAL SCREW. FLUOROSCOPIC IMAGING CONFIRMED THAT THE SCREW SLOT WAS FULLY OPENED; HOWEVER, THE DRILL CONTINUED TO CONTACT METAL INSTEAD OF ENTERING THE SLOT. THIS WAS DISCOVERED DURING A PANTALAR ARTHRODESIS USING THE TTC HINDFOOT NAIL PROCEDURE WITH NO PATIENT HARM REPORTED. TO COMPLETE THE CASE, THE JIG WAS REPOSITIONED TO A MEDIAL-TO-LATERAL ORIENTATION, AND THE TEAM FREE-DRILLED TO LOCATE THE SLOT WITHIN THE NAIL, ALLOWING MEASUREMENT AND IMPLANTATION OF THE SCREW.

  Patient problems: Insufficient Information

  MAUDE report 24618274 ↗
• MalfunctionMar 17, 2026Material Twisted/Bent

  ON (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9091-01 HINDFOOT NAIL TARGETING GUIDE HAD ALIGNMENT ISSUES AND AN AR-9091-02 HINDFOOT NAIL CABLE TENSIONER WOULD NOT TENSION. THIS WAS DISCOVERED DURING AN PANTALAR ARTHRODESIS FOR CHARCOT FOOT WITH USAGE OF TTC NAIL PROCEDURE WITH NO PATIENT HARM. IT WAS REPORTED THAT DURING THE PROCEDURE, THE AR-9091-02 HINDFOOT NAIL CABLE TENSIONER DID NOT FULLY OPEN THE PROXIMAL CALCANEAL SCREW SLOT. THE DEVICE WAS REMOVED WHILE THE NAIL REMAINED IN THE PATIENT AND WAS RESET TO ZERO TENSION. THE CABLES WERE THEN RE-ROUTED THROUGH THE RESET CABLE TENSIONER IN AN ATTEMPT TO OPEN THE PROXIMAL CALCANEAL SLOT; HOWEVER, THE SLOT DID NOT FULLY OPEN AS THE DEVICE APPEARED UNABLE TO MAINTAIN FULL TENSION. THE AR-9091-01 HINDFOOT NAIL TARGETING GUIDE DID NOT ALIGN WITH THE SCREW SLOT. THE CASE WAS COMPLETED USING INSTRUMENTS FROM THE 5.0/7.0 TRAY, PLACING A 1.6 WIRE AND DRILLING WITH A 3.2¿MM CANNULATED DRILL TO CREATE THE TUNNEL, AFTER WHICH THE 5.0 SCREW FROM THE HINDFOOT SET WAS PLACED.

  Patient problems: Insufficient Information

  MAUDE report 24617945 ↗
• MalfunctionMar 17, 2026Positioning Failure

  ON (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-9091-01 HINDFOOT NAIL TARGETING GUIDE HAD ALIGNMENT ISSUES AND AN AR-9091-02 HINDFOOT NAIL CABLE TENSIONER WOULD NOT TENSION. THIS WAS DISCOVERED DURING A PANTALAR ARTHRODESIS PROCEDURE WITH AN HOUR-LONG DELAY EXPERIENCED AND NO PATIENT HARM REPORTED. IT WAS REPORTED THAT AFTER IMPLANTATION OF THE NAIL AND PLACEMENT OF THE FIRST AND SECOND CONSTRUCT SCREWS, THE AR-9091-02 HINDFOOT NAIL CABLE TENSIONER FAILED TO MAINTAIN CABLE TENSION. THE TIBIAL SCREW WAS REMOVED, AND THE DEVICE WAS TAKEN OFF THE IMPLANTED NAIL. A SECOND COMPRESSION DEVICE WAS APPLIED, THE TIBIAL SCREW WAS REINSERTED, AND COMPRESSION WAS ACHIEVED USING A BACKUP TENSIONER. FLUOROSCOPY CONFIRMED TENSION AND FULL OPENING OF THE SCREW SLOTS. FOLLOWING THIS, THE AR-9091-01 HINDFOOT NAIL TARGETING GUIDE DID NOT ALIGN WITH THE THIRD CONSTRUCT SCREW (PROXIMAL POSTERIOR-TO-ANTERIOR CALCANEAL SCREW). EXCESSIVE MOVEMENT IN THE TARGETING SLOT FOR SCREW 3 WAS NOTED, RESULTING IN MISSED ALIGNMENT BOTH PROXIMALLY AND MEDIAL-LATERALLY. THE CASE WAS COMPLETED WITHOUT ANY HARM TO PATIENT AND IMPLANT SUCCESSFULLY WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617397 ↗
• MalfunctionAug 12, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9091-01 HINDFOOT NAIL IS NOT LINING UP CORRECTLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782268 ↗
• MalfunctionJul 18, 2025Break; Break

  ON 06/25/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9091-01 HINDFOOT NAIL TARGETING GUIDE BROKE DURING A CASE. THIS DID NOT AFFECT PATIENT OUTCOME AS THEY HAD A BACKUP SET AT THE TIME. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542445 ↗
• MalfunctionJan 28, 2025Break; Break

  ON (B)(6) 2025 IT WAS REPORTED BY A SALES REPRESENTATIVE, VIA (B)(4), THAT AN AR-9091-01 HINDFOOT NAIL TARGETING GUIDE BROKE. THIS OCCURRED DURING A CASE WHEN TORQUE COMPRESSION WAS BEING PERFORMED. THE DEVICE BROKE THE CARVING JIG, RENDERING THE DEVICE NO LONGER USABLE. THE DEVICE WAS SWAPPED AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251366 ↗
• MalfunctionNov 19, 2024Crack; Crack

  ADDITIONAL INFORMATION PROVIDED ON 11/13/2024 BY A SALES REPRESENTATIVE WHO STATED THE EVENT OCCURRED ON 10/23/2024 AND THE PROCEDURE PERFORMED WAS A HINDFOOT FUSION. THE IMPACTOR PAD SNAPPED OFF IN THE TARGETER DURING IMPACTION OF THE NAIL. AN ARTHREX REP WAS PRESENT DURING THE CASE. THE PATIENT'S BONE QUALITY WAS AVERAGE. NO FRAGMENTS BROKE OFF IN THE PATIENT. THERE WAS NO ADDITIONAL ANESTHESIA NEEDED AND NO DELAY TO THE PROCEDURE.

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

  MAUDE report 20724099 ↗
• MalfunctionSep 10, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06640999 THAT AN AR-9091-02 HINDFOOT NAIL CABLE TENSIONER ARRIVED JAMMED IN THE CENTRAL POSITION (HALF COMPRESSED) AND WAS VERY DIFFICULT TO GET SLIDING AGAIN (HAD TO ATTACH TENSIONER TO THE JIG AND CRANK VERY HARD, FINALLY BROKE THROUGH THE JAM). THIS OCCURRED DURING A CASE. THERE WAS A LOT OF PLAY IN THE JIG WHERE THE TENSIONER/JIG CONNECTED TO THE AR-9091-01 HINDFOOT NAIL TARGETING GUIDE WAS SEPARATING EVEN THOUGH IT WAS SUPPOSED TO BE LOCKED. THE DISTAL CALC SCREW AND DISTAL TIBIAL SCREW MISSED THE NAIL. THEY HAD TO FREEHAND PERFECT CIRCLES ON THE TIBIA, WITH PERFECT CIRCLES VISUALIZED ON THE NAIL VIA X-RAY, YOU COULD CLEARLY SEE THE JIG NOT LINING UP WITH THE TIBIAL SCREW HOLES.

  Patient problems: Insufficient Information

  MAUDE report 20182323 ↗
• MalfunctionJul 12, 2024Break; Break

  ON 6/19/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9091-31 HINDFOOT NAIL, IMPACTION ROD, HAD THE NAIL INSERTED IN THE JIG OF AN AR-9091-01 HINDFOOT NAIL TARGETING GUIDE. WHILE PUTTING IT THROUGH AS INSTRUCTED, IT CAUSED A THREAD AND BROKE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/25/2024: THIS WAS DISCOVERED DURING A REVISION TTC FUSION PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED WITH THE SURGEON USING THEIR TTC NAIL. THREADS OF IMPACTION ROD REMAINED IN THE JIG. THERE WAS NO DELAY CAUSED BY THE BREAKAGE. NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730050 ↗