T2 ALPHA 2353-4107Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327357080), received between Mar 11, 2019 and May 18, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A TIBIAL NAIL PROCEDURE, THE TARGETER WOULD NOT ALLOW THE SCREW TO ENGAGE THE NAIL. THE TARGETING ASSEMBLY WAS REMOVED AND THE SCREW WAS IMPLANTED FREE-HAND. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 10-15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427749 ↗
• MalfunctionJan 23, 2021Fracture; Fracture

  AS REPORTED: "SURGEON TURNED LOCKING KNOB TOO TIGHT AND THE KNOB CRACKED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11219888 ↗
• MalfunctionOct 5, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED: "RIGHT TIBIA T2 ORIF. AFTER ASSEMBLING THE NAIL ADAPTER TIBIA AND THE TARGETING ARM TIBIA, THE SCREW WAS INSERTED. AFTER THAT, I TRIED TO REMOVE IT, BUT IT COULD NOT BE REMOVED." DELAY OF 4-5 MINUTES. "AT THE TIME OF THE EVENT, THE PROXIMAL SCREW HAD BEEN INSERTED, SO IT WAS REMOVED FROM THE NAIL AND THE DISTAL SCREW WAS INSERTED (RADIOLUCENT DRILL)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10632035 ↗
• MalfunctionOct 29, 2019Break

  AS REPORTED: "WHILE NAIL WAS BEING IMPLANTED IT WAS POINTED OUT THE [T2 ALPHA TIBIAL] TARGETING ARM WAS BROKEN. CASE WAS COMPLETED."

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9251726 ↗
• MalfunctionOct 3, 2019Break; Crack

  AS REPORTED: "THE SLEEVE RETENTION BUTTON ON THE SIDE OF THE PROXIMAL AIMING JIG FOR THE T2 ALPHA TIBIA CRACKED AND BROKE WHILE INSERTING / REMOVING A SLEEVE." PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9153645 ↗
• MalfunctionAug 2, 2019Fracture; Crack; Fracture

  COMPANY REPRESENTATIVE REPORTED THE FOLLOWING: "AFTER A SURGERY WAS SUCCESSFULLY COMPLETED, I WAS PUTTING THE INSTRUMENTS BACK INTO THE TRAY AND NOTICED THE GREY KNOB TO LOCK THE TARGETING ARM TO THE NAIL ADAPTOR WAS CRACKED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8858054 ↗
• MalfunctionJul 22, 2019Crack

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT TIBIA, THE KNOB ON THE TARGETER WAS OBSERVED TO BE CRACKED. THE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO REPORTED SURGICAL DELAY OR ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8814457 ↗
• MalfunctionJul 18, 2019Crack

  WHEN THE NAIL WAS INSERTED, THE GRAY PLASTIC LOCK NUT CRACKED ON THE TARGETING ARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804878 ↗
• MalfunctionJul 18, 2019Fracture; Crack; Fracture

  FIELD WAREHOUSE TEAM NOTICED THAT THE KNOB OF THE TIBIA TARGETING ARM IS CRACKED. THE DEVICE IS STILL FUNCTIONAL. NOT KNOWN WHEN OR UNDER WHAT CIRCUMSTANCES THE DEVICE CRACKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804435 ↗
• MalfunctionJun 3, 2019Fracture; Break; Fracture

  AS REPORTED: "SURGEON WAS IMPACTING NAIL AND A PIECE OF THE KNOB ON THE TARGETING ARM BROKE". PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8664432 ↗
• MalfunctionMay 17, 2019Break

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF HOSPITAL INVENTORY, THE THREADS ON THE IMPACTOR, INSIDE THE TIBIA TARGETER, AND INSIDE THE GREATER TROCH TARGETER WERE FOUND TO BE STRIPPED. NO ASSOCIATED PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8621421 ↗
• MalfunctionMar 11, 2019Defective Component

  SURGEON REPORTED THE FEEDBACK ON HIS 2ND AND 3RD CASE ALREADY, IN WHICH HE IMPLANTED T2 ALPHA TIBIAL NAILS OF DIFFERENT DIMENSIONS IN THE STATIC LOCKING MODE VIA THE SUPRAPATELLAR APPROACH. THE RATINGS GIVEN BY THE SURGEON ARE ALL POSITIVE; HOWEVER, AS PART OF THE ADDITIONAL COMMENTS MADE, A COMPLICATION WAS ALSO REPORTED IN THE FEEDBACK ON CASE #040. NAIL CROSS THREADED ONTO THE JIG AND MISSED ONE OF THE PROXIMAL LOCKERS. INDICATED AS AN OBSERVED DEFICIENCY / COMPLICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8409351 ↗