T2 1806-1401Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327005394), received between Oct 12, 2021 and Jun 23, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILST CONNECTING A T2 TIBIAL NAIL TO THE T2 SUPRAPATELLA NAIL ADAPTOR, THE SURGEON NOTED THAT ALTHOUGH THE NAIL WAS CORRECTLY ALIGNED WITH THE ADAPTOR, IT STILL HAD SOME MOVEMENT. HE TIGHTENED THE BOLT AS MUCH AS HE COULD TO NO AVAIL. HE DECIDED TO REMOVE THE BOLT AND TRY AGAIN ONLY TO FIND THAT THIS WAS NOT POSSIBLE. THE BOLT APPEARED TO HAVE COLD WELDED INTO THE NAIL. THE SURGEON HAD TO SWITCH TO THE INFRAPATELLA INCISION. HE HAD ALREADY COMPLETED REAMING THROUGH THE SUPRAPATELLA INCISION SO THE CHANGE WAS RELATIVELY SIMPLE. HE REAMED TO THE NEXT NAIL DIAMETER AND INSERTED THE NAIL USING THE T2 INFRAPATELLA NAIL ADAPTOR. THERE WAS A DELAY OF ABOUT 10 MINUTES IN THE PROCEDURE WHILST THE SURGEON TRIED TO SEPARATE THE NAIL FROM THE BOLT. THE PATIENT WAS ADVERSELY AFFECTED, AS AN EXTRA INCISION HAD TO BE MADE TO ACCOMMODATE THE NEW ENTRY POINT FOR THE NAIL.

  Patient problems: Insufficient Information

  MAUDE report 14787873 ↗
• MalfunctionNov 10, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING IMPLANTATION OF A T2 TIBIAL NAIL USING THE SUPRAPATELLAR INSTRUMENTATION THE NAIL APPEARED TO HAVE GOTTEN FUSED TO THE NAIL HOLDING BOLT AND INSERTION ARM. THE STAFF SPENT 10-15 MINUTES ATTEMPTING TO DISENGAGE THE NAIL BUT WERE UNABLE TO. THEY ELECTED TO USE THE STANDARD APPROACH WITH A NEW NAIL. THE NAIL WAS ABLE TO BE DISENGAGED AFTER IT WAS RETURNED TO STRYKER CANADA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12785968 ↗
• MalfunctionOct 12, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A CASE USING A T2 TIBIAL NAIL THE NAIL HOLDING SCREW [PN 1806-1401] WAS JAMMED IN THE NAIL ADAPTOR [PN 1806-1402] . WE SWITCHED FROM SUPRAPATELLAR TO INFRAPATELLAR. A SECOND INCISION HAS TO BE MADE AND 20MIN DELAY IN SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12614178 ↗