T2 1806-3211Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540708489), received between Feb 13, 2020 and Dec 23, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Mechanical Jam; Naturally Worn; Mechanical Jam; Naturally Worn

  AS REPORTED: "AFTER THE SURGERY, THE INSTRUMENTS WAS DIFFICULT TO BE DISASSEMBLED AS CONNECTION PART OF THE NAIL ADAPTER WAS WORN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882689 ↗
• MalfunctionFeb 21, 2025Mechanical Jam; Mechanical Jam

  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 21437928 ↗
• 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 15749095 ↗
• InjurySep 26, 2022Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "AT THE START OF THE MEDICAL PROCEDURE IN THIS CLINIC, THE BLOODY NAIL HOLDING SCREW 1806-3203 (LOANER) FROM THE LAST SURGERY OF THE PREVIOUS PATIENT WAS STILL IN THE NAIL HOLDING ADAPTER 1806-3211. THIS WAS OVERLOOKED DURING THE KIT INSPECTION, AND A NEW NAIL HOLDING SCREW WAS ADDED INSTEAD. THE INSTRUMENT SET WAS THEREFORE HYGIENICALLY NOT OK AND COULD NOT BE USED FOR THE SURGERY. PATIENT RECEIVED UNNECESSARY ANESTHESIA. THE SURGERY WAS CANCELLED AND WILL BE MADE UP ON MONDAY (B)(6) 2022 UNDER STERILE HYGIENIC CONDITIONS." ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED HOWEVER THE LENGTH OF THE EXTENSION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15485978 ↗
• InjuryJul 28, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "IN PRACTICE, THE NUT REMAINED LOCKED TO THE NAIL ADAPTER BLOCK. THEREFORE WE HAD TO INTERRUPT THE OPERATION, BECAUSE IT WAS NO LONGER POSSIBLE TO CONNECT THE CENTERING DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120473 ↗
• MalfunctionJun 11, 2021Component Missing; Component Missing

  THE FOLLOWING WAS REPORTED: AN ANKLE ARTHRODESIS WITH THE T2 SGA NAIL WAS TO TAKE PLACE. WHEN THE SALES REP ARRIVED, HE WAS INFORMED THAT THE LOANER INSTRUMENTS HAD NOT BEEN DELIVERED IN COMPLETE FORM. THE PATIENT WAS ALREADY ANESTHETIZED AND THE SURGERY HAD ALREADY BEGUN. THE SALES REP'S INTERNAL CLINIC INVESTIGATION REVEALED THAT TWO ESSENTIAL COMPONENTS (ITEM# 18063211 AND ITEM# 18063203) HAD NOT BEEN SUPPLIED. THE SALES REP WAS ASKED WHICH HOSPITAL NEARBY HAD THE SYSTEM PERMANENTLY INSTALLED. THE DEVICES WERE REQUESTED FROM THE NEARBY HOSPITAL. THEY WERE DELIVERED, AND THE SURGERY WAS COMPLETED. THERE WAS A 60-MINUTE SURGICAL DELAY DUE TO THIS ISSUE. AS A RESULT, THE ANESTHESIA HAD TO BE PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982847 ↗
• MalfunctionFeb 13, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  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 9705750 ↗