CrossTIE™ 2.5mm 10Deg w/ Universal InserterRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00815432022052), received between Dec 4, 2019 and Sep 29, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2022Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATES THAT THE SURGEON IMPLANTED A 2.5 CROSSTIE, PART NUMBER 1443-2511 LOT NUMBER 105448. THE SURGEON IMPLANTED IT AND WAS GOING TO BEGIN SUTURE AND GRABBED THE TOE AND THE IMPLANT BROKE IN HALF. THE SURGEON PULLED ONE OUT AND THE OTHER END WAS DRILLED OUT. REMOVAL AND REIMPLANT WAS ABOUT 4 MINUTES LONG. AN ALTERNATE IMPLANT WAS PLACED WITH MINIMAL SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501822 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  BROKEN CROSSTIE IMPLANT WAS FOUND DURING ECOPAK RECEIVING ON 03/13/2017. EMAIL CORRESPONDENCE TO THE REP CONCERNING THIS WILL BE INCLUDED IN THIS FILE. THE REP PROVIDED THE SURGEON NAME AND DATE. THE REP CLAIMED, "THE DOCTOR TWISTED THE INSERTER TOO HARD WHILE PUSHING OR JUST HAD IT AT THE RIGHT ANGLE SO IT SNAPPED." OTHER KITS WERE USED ON OTHER TOES, INCLUDING ONE FROM THE SAME LOT NUMBER, AND THERE WERE NO ADDITIONAL ISSUES. THE DOCTOR OPTED TO LEAVE PROXIMAL END OF THE IMPLANT IN THE PATIENT AND A K-WIRE WAS PLACED NEXT TO IT FOR STABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501616 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  BROKEN CROSSTIE IMPLANT WAS FOUND DURING ECOPAK RECEIVING ON 02/20/2017. REP WAS CALLED FOR QUESTIONS. REP GAVE FACILITY AND DOCTOR NAME AND MENTIONED THAT HE THINKS THE CASE HAPPENED IN (B)(6) OF 2016. THIS INFO WAS USED TO FIND THE INVOICE FOR THE CASE. THIS INVOICE IS THE ONLY CASE WITH THIS DOCTOR IN WHICH MULTIPLE CROSSTIE KITS WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501603 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  BROKEN IMPLANT RECOVERED IN ECOPAK RETURNED BY REP. DETAILS OF CASE WERE OBTAINED DURING A PHONE CALL WITH REP IN WHICH IT WAS STATED THAT THE FAILURE WAS DUE TO THE DOCTOR APPLYING TOO MUCH SHEAR FORCE WHILE ATTEMPTING TO RELEASE THE IMPLANT FROM THE INSERTER. THE PROXIMAL PIECE OF THE BROKEN IMPLANT WAS SUCCESSFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501547 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  A CROSSTIE IMPLANT WAS BROKEN DURING INSERTION. A 2.5 MM REAMER WAS USED IN THIS CASE PER THE FIELD UPDATE THAT WAS ISSUED. THE FAILURE OCCURRED WHILE THE DOCTOR WAS ATTEMPTING TO INSERT THE IMPLANT INTO THE UNSTABLE PROXIMAL PHALANX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501500 ↗
• MalfunctionSep 29, 2022Fracture; Fracture

  CROSSROADS RECEIVED A BROKE CROSSTIE IMPLANT THAT WAS STILL LODGED IN THE INSERTER ON (B)(6) 2016. CONTACT WAS MADE WITH EVENT REPORTER AND IT WAS DISCOVERED THAT THE IMPLANT BROKE DURING INSERTION. ANOTHER KIT WAS OPENED AND SUCCESSFULLY USED. BROKEN FRAGMENTS OF IMPLANT WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501423 ↗
• InjuryDec 4, 2019Fracture; Fracture

  DURING A ROUTINE 4 WEEK FOLLOW UP VISIT, THE DOCTOR DISCOVERED THE MIDDLE PHALANX HAD FRACTURED AND THE IMPLANT HAD BROKEN THROUGH THE BONE AND PUNCTURED THE SKIN. THE DOCTOR MENTIONED THAT THE BONE WAS VERY SOFT AND THE FRACTURE WAS CAUSED BY WALKING, HE MENTIONED THAT THE IMPLANT DID NOT EXPERIENCE MECHANICAL FAILURE. THE DOCTOR EASILY REMOVED THE IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 9410955 ↗