CrossTIE™ 2.5mm 0Deg w/ Universal InserterRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815432022045), received between Sep 29, 2022 and Sep 29, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Fracture; Fracture

  A CROSSTIE IMPLANT FRACTURED DURING INSERTION. THE IMPLANT WAS BEING INSERTED WITH A UNIVERSAL INSERTER AND THE HOLE WAS REAMED WITH A 2.2 REAMER. THE PATIENT HAD SLIGHTLY POOR/SOFT BONE QUALITY. THERE WAS NO HARM TO THE PATIENT. THE IMPLANT WAS REMOVED AND ANOTHER 2.5MM IMPLANT WAS SUCCESSFULLY INSERTED. THE INCIDENT RESULTED IN AN ESTIMATED 5-MINUTE DELAY IN SURGERY AND DOCTOR WAS PLEASED WITH THE OUTCOME AND DID NOT HAVE ANY NEGATIVE COMMENTS REGARDING THE BROKEN IMPLANT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS SUCCESSFULLY INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15502064 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  A 2.5 MM CROSSTIE IMPLANT BROKE WHILE BEING INSERTED WITH A UNIVERSAL INSERTER. A 2.2 REAMER WAS USED BECAUSE THE REP WAS NOT NOTIFIED OF THE ORIGINAL FIELD UPDATE THAT WAS ISSUED AS AN ACTION PLAN . PER THE REP, HE DID NOT NOTICE ANY TORQUE BEING APPLIED ON THE IMPLANT PRIOR TO THE FAILURE. THE FAILURE OCCURRED WHILE ATTEMPTING TO INSERT THE IMPLANT INTO THE DISTAL END OF THE PROXIMAL PHALANX. THE IMPLANT WAS REMOVED AND ANOTHER CROSSTIE KIT WAS OPENED AND SUCCESSFULLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501661 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  BROKEN CROSSTIE IMPLANT WAS FOUND IN ECOPAK RETURNED BY REP. DETAILS OF CASE WERE RECEIVED DURING A PHONE CALL WITH REP DURING WHICH IT WAS STATED THAT FAILURE WAS DUE TO DOCTOR APPLYING TOO MUCH SHEAR FORCE WHILE TRYING TO REMOVE THE IMPLANT FROM THE INSERTER. PROXIMAL PIECE OF BROKEN IMPLANT WAS SUCCESSFULLY REMOVED. ANOTHER CROSSTIE KIT WAS OPENED AND SUCCESSFULLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501632 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  IMPLANT BROKE WHILE DOCTOR WAS ATTEMPTING TO INSERT THE IMPLANT PROXIMALLY. A K-WIRE WAS USED AND IMPLANT REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501626 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  TWO CROSSTIE IMPLANTS WERE BROKEN DURING INSERTION (P/N 1443-2501 LOT 101930 AND P/N 1444-2500 LOT 100944). A THIRD IMPLANT (P/N 1443-2501 LOT 101930) WAS SUCCESSFULLY IMPLANTED BUT THEN REMOVED AFTER TWO WERE BROKEN. THIS WAS DONE DUE TO DOCTOR PREFERENCE. THE IMPLANTS ARE SUPPOSED TO BE RETURNED THROUGH AN ECOPAK. REP CALLED AND GAVE DETAILS REGARDING THE SURGERY WHERE HE REPORTED THE INCIDENT IS DUE TO USER ERROR CAUSED BY TORQUEING THE INSERTER TOO QUICKLY WHILE TRYING TO GET THE IMPLANT TO RELEASE FROM THE INSERTER. ALL THREE IMPLANTS WERE REMOVED AND K-WIRES WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501619 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  DURING SURGERY, TWO OF THE CROSSTIE IMPLANTS BROKE. A 2.2 REAMER WAS USED DURING PREP. THIS EVENT OCCURRED PRIOR TO THE FIELD UPDATE REGARDING THE USE OF 2.5 REAMERS. THIS FAILURE OCCURRED DUE TO THE DOCTOR TRYING TO FORCE THE 2.5MM IMPLANT INTO THE HOLE DRILLED BY THE 2.2MM REAMER. DURING THIS THE PROXIMAL PHALANX WAS UNSTABLE AND THE IMPLANT BROKE AS RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501487 ↗