T2 1806-3212Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04546540708496), received between Apr 30, 2019 and Jul 10, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Failure to Align

  AS REPORTED: "DURING A T2-SGA PROCEDURE, THE TARGETING DEVICE FAILED TO ENGAGE EITHER OF THE TWO PROXIMAL SCREWS IN THE TIBIA OR THE DISTAL SCREW IN THE CALCANEUS. IN BOTH CASES, THE TARGETING DEVICE HAD TO BE REMOVED AND A FREEHAND LOCKING PROCEDURE ATTEMPTED. WHILE THE PLACEMENT OF THE TWO PROXIMAL SCREWS IN THE TIBIA WAS SUCCESSFUL USING THIS METHOD, THE PLACEMENT OF THE SCREW IN THE CALCANEUS WAS NOT. THE ACCURACY OF THE TARGETING DEVICE WAS VERIFIED IN ADVANCE BY MARKING THE SITE WITH THE SLEEVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25779912 ↗
• MalfunctionApr 1, 2026Failure to Align

  AS REPORTED: "WHEN A DRILL WAS USED TO INSERT A SCREW FROM THE POSTERIOR SIDE OF THE CALCANEUS, THE DRILL DID NOT PASS THROUGH THE NAIL HOLE AND INSTEAD CONTACTED THE FRONT OF THE NAIL. THE DRILL BROKE AND THE BROKEN PIECES REMAINED INSIDE THE CALCANEUS. AN ADDITIONAL SKIN CUT WAS REQUIRED TO REMOVE THE DRILL FROM THE BONE, WHICH EXTENDED THE SURGERY TIME."

  Patient problems: Perforation

  MAUDE report 24753034 ↗
• MalfunctionMar 5, 2026Failure to Align

  AS REPORTED: "THE T2 ANKLE TARGETING GUIDE WAS CONTINUOUSLY MISSING THE INTENDED SCREW HOLES IN THE RESPECTIVE NAIL".

  Patient problems: Insufficient Information

  MAUDE report 24524121 ↗
• MalfunctionFeb 6, 2026Failure to Align

  AS REPORTED: "WE HAVE HAD A CASE TODAY WHERE THE DRILL AND SCREW MISSED THE POSTERIOR LOCKING HOLE OF THE NAIL THROUGH THE JIG. THE JIG WAS ALSO STIFF TO LOCK INTO THE POSTERIOR LOCKING HOLE." FURTHER INFORMATION FROM REP RECEIVED: "THE SURGEON REDRILLED FOR TALUS SCREW AND SCREW THEN WENT IN FINE. SURGEON DID NOT USE THE POSTERIOR SCREW AS IT KEPT MISSING THE HOLE IN THE NAIL THROUGH THE JIG. THE JIG WAS STIFF BUT IT WOULD STILL LOCKING INTO POSITION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283906 ↗
• MalfunctionOct 15, 2025Failure to Align; Failure to Align

  AS REPORTED: "THE SCREWS DO NOT HIT THE CORRECT POSITION DUE TO THE TARGET DEVICE. THE SCREWS WERE USED MANUALLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299916 ↗
• MalfunctionJun 18, 2025Failure to Align; Failure to Align

  SALES REP REPORTED THE FOLLOWING: "CAN YOU CHECK THE ACCURACY OF THE SIGHT (REF. 1806-3212) AS WE HAD A LOT OF PROBLEMS WITH IT? ADDITIONAL INFO: THE AIM FOR THE POSTERIOR ANTERIOR SCREW WAS NOT CORRECT." UPDATE RECEIVED 17 JUN 2025. "CAN YOU GET MORE CLARIFICATION ON WHEN IT STATES "CAN YOU CHECK THE ACCURACY OF THE SIGHT (REF. 1806-3212) AS WE HAD A LOT OF PROBLEMS WITH IT?"... "THE AIM FOR THE POSTERIOR ANTERIOR SCREW WAS NOT CORRECT" THE POSTERIOR ANTERIOR SCREW ARRIVED NEXT TO THE NAIL. HOW WAS THE ISSUE SOLVED? E.G. SPARE PART, FREE-HAND-TECHNIQUE THE SURGEON WAS LUCKY AND WAS ABLE TO REMOVE THE SCREW. HE DIDN'T PUT IT BACK IN."

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

  MAUDE report 22287651 ↗
• InjuryMay 6, 2025Failure to Align; Failure to Align

  AS REPORTED: "ANKLE NAIL WAS INTRODUCED. SCREWS WERE LOCKED. MOST DISTAL CALCANEAL SCREW TRAJECTORY WAS DRILLED WITH A 4.2MM DRILL, TROUGH THE TARGETING DEVICE. THE DRILL DIDN'T END UP IN THE HOLE BUT SCRATCHED THE NAIL ON THE SIDE. THE NAIL WAS REMOVED, TESTED AND RE-INSERTED. THE INCIDENT HAPPENED AGAIN. THIS WAS TRIED 3 TIMES. SURGERY WAS DELAYED BY 2 HOURS. A PLATE WAS USED TO FUSE THE ANKLE, WHICH LEAD TO EXTRA INCISION AND DUE TO THE PLATE, NO BONE GRAFT COULD BE USED, WHICH WAS PLANNED."

  Patient problems: Insufficient Information

  MAUDE report 21966993 ↗
• MalfunctionApr 22, 2025Failure to Align; Failure to Align

  AS REPORTED: "WHEN DRILLING FOR INSERTION OF A PA SCREW INTO THE CALCANEUS, THE DRILL MISSED THE SCREW HOLE AND GRAZED THE NAIL. WHEN TRYING TO REMOVE THE DRILL WHILE TURNING, THE DRILL BIT BROKE OFF. WHEN DRILLING AGAIN WITH A SPARE DRILL, IT BROKE OFF IN THE SAME WAY".

  Patient problems: Insufficient Information

  MAUDE report 21883052 ↗
• MalfunctionMar 17, 2025Failure to Align; Failure to Align

  AS REPORTED: "THE TARGET ARM NO LONGER SEEMS TO FUNCTION PROPERLY, THE CALCANEUS SCREW WAS MISSED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621803 ↗
• MalfunctionMar 17, 2025Failure to Align; Failure to Align

  AS REPORTED: "THE TARGET ARM NO LONGER SEEMS TO FUNCTION PROPERLY, THE CALCANEUS SCREW WAS MISSED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621801 ↗
• MalfunctionMar 14, 2025Failure to Align; Failure to Align

  AS REPORTED: "THE TARGET ARM NO LONGER SEEMS TO FUNCTION PROPERLY, THE CALCANEUS SCREW WAS MISSED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21608794 ↗
• MalfunctionFeb 21, 2025Failure to Align; Failure to Align

  AS REPORTED: "THE END USER HAS REPORTED THAT AN ISSUE HAS OCCURRED DURING THE T2 ANKLE FUSION SURGERY PERFORMED. AFTER SUCCESSFULLY PLACING THE DYNAMIC COMPRESSION SCREWS AND PROXIMAL STATIC SCREWS, THEY ENCOUNTERED A PROBLEM WHILE ATTEMPTING TO PLACE THE POSTERIOR CALCANEUS SCREWS. THE DRILL WAS UNABLE TO PASS THROUGH THE NAIL AND INSTEAD HIT THE NAIL, NOT GOING THROUGH THE DEDICATED HOLE AS INTENDED. THE SURGEON WAS UNABLE TO GENERATE PROPER COMPRESSION TO ENHANCE THE FUSION PROCEDURE, WHICH SIGNIFICANTLY IMPACTED THE OUTCOME OF THE SURGERY. DUE TO THE DEFECT, THE SURGEON HAD TO FREEHANDEDLY INSERT THE SCREW, WHICH CAUSED A SIGNIFICANT DELAY AND INCONVENIENCE, AFFECTING THE OVERALL OPERATING TIME".

  Patient problems: Insufficient Information

  MAUDE report 21440293 ↗
• InjuryMar 20, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT PATIENT PRESENTED POST OP. UPON X-RAY IT WAS NOTED THAT THE SCREW MISSED THE NAIL USING THE OUTRIGGER AND ENDED UP CAUSING A FRACTURE. ALLEGEDLY, THE PATIENT MAY NEED TO UNDERGO A SECOND SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 16572222 ↗
• InjuryJan 6, 2023Failure to Align; Failure to Align

  AS REPORTED: "THE JIG IS NOT ALIGNING WITH THE PROXIMAL LOCKING HOLES AND THEREFORE HAD AN 'AIRSHOT'. THE LOCKING WAS THEN COMPLETED FREEHAND BUT UNFORTUNATELY POST OP THE PATIENT STOOD AND TWISTED AND HAS SUSTAINED A FRACTURE AROUND THE PROXIMAL PART OF THE NAIL WHERE THEY HAD DRILL, PROBABLY THROUGH THE STRESS RISER CAUSED BY THE HOLE IN THE BONE".

  Patient problems: Limb Fracture

  MAUDE report 16113127 ↗
• MalfunctionNov 7, 2022Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  AS REPORTED: "DURING THE SET UP FOR AN ANKLE ARTHRODESIS CASE, WE DISCOVERED THAT THE NAIL ADAPTOR WASN¿T FITTING INTO THE LATERAL LOCKING POSITION OF THE JIG. WE TRIED TO LUBRICATE IT WITH SALINE BUT HAD NO LUCK. THE SURGEON ENDED UP USING A MALLET TO PUSH THE ADAPTOR/JIG INTO THE CORRECT POSITIONS DURING THE WHOLE CASE POTENTIALLY FURTHER DAMAGING THE INSTRUMENTS. THIS WAS DIFFICULT AS THE JIG WOULD GET STUCK OR NOT GO INTO THE CORRECT POSITION HOW IT NORMALLY WOULD. THIS LED TO INCREASED SURGICAL TIME. (INCREASE OF APPROXIMATELY 5 MINUTES). THE ISSUE WAS FIRST NOTICED WHEN THE SCRUB NURSE WAS PUTTING THE JIG AND NAIL ADAPTOR TOGETHER BEFORE THE CASE STARTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748838 ↗
• MalfunctionJul 15, 2020Failure to Align; Failure to Align

  AS REPORTED: DURING SURGERY THE POSTERIOR SCREW COULD NOT BE INSERTED BECAUSE THE DRILL BIT HIT THE NAIL THROUGH THE SLEEVE ON THE TARGET DEVICE. I ALSO INSERTED THE T2 ANKLE NAIL INTO THE TARGET DEVICE AFTERWARDS - NO DRILL BIT FITS THROUGH THE SLEEVE INTO THE LATERAL STATIC/DYNAMIC HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10279835 ↗
• MalfunctionFeb 13, 2020Difficult or Delayed Positioning; Failure to Align; Difficult or Delayed Positioning; Failure to Align

  IT WAS REPORTED THAT DURING A PRIMARY T2 ANKLE ARTHRODESIS NAIL PROCEDURE, THE LATERAL CALCANEUS HOLE OF THE TARGETER DID NOT ALIGN WITH THE IMPLANT. THE PROCEDURE WAS COMPLETED BY INSERTING THE SCREW WITHOUT THE USE OF THE TARGETER. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. REP WAS NOT PRESENT FOR THE PROCEDURE, AND CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9705805 ↗
• MalfunctionApr 30, 2019Mechanical Problem; Fitting Problem; Material Deformation; Material Deformation

  SALES AGENCY ODY-C REPORTED THE FOLLOWING EVENT : "WHILE IMPLANTING THE T2 ANKLE NAIL SURGEON ENCOUNTERED A PROBLEM WITH THE NAIL HOLDER. IT WAS IMPOSSIBLE TO CORRECTLY LOCK THE REAR SIGHT GUIDE ON THE NAIL HOLDER. IMPOSSIBLE WITH THE NAIL HOLDER TO DO THE POSTERIOR LOCKING OF THE CALCANEUM. ANCILLARY EQUIPMENT TO BE CHECKED ON RETURN. " CLINICAL CONSEQUENCES FOR THE PATIENT: NO POSTERIOR ANTERIOR CALCANEAL LOCKING DESPITE 2 ATTEMPTS. THERE WAS AN INCREASE IN TOURNIQUET TIME FOR THE PATIENT BECAUSE THERE WAS AN PROBLEM WITH CHECKING THE LOCKS WHEN MOUNTING THE NAIL. THE PIN THAT SHOULD THEORETICALLY FIT INTO THE SIGHT ADAPTER DID NOT FIT PROPERLY INTO THE POSTERIOR LOCKING HOLE OF THE NAIL. 2 FAILED ATTEMPTS TO LOCK THE CALCANEUM AFTER THE FACT. THE INTERVENTION HAS BEEN DELAYED APPROXIMATE HALF AN HOUR. NO ADDITIONAL MEDICAL INTERVENTION TO DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8566529 ↗