T2 1822-1134SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540198044), received between Mar 11, 2022 and Aug 9, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19956403 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, DELAYED UNION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Impaired Healing

  MAUDE report 19954215 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Implant Pain

  MAUDE report 19938371 ↗
• InjuryJun 23, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  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 14787444 ↗
• InjuryMar 11, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED: "THE NAIL WAS IMPLANTED ON (B)(6) 2015. IT IS A STRYKER TIBIAL NAIL T2 STRYKER, 345 MM, SIZE 11. POSTOPERATIVELY, THE PATIENT INITIALLY UNDERWENT PARTIAL WEIGHT-BEARING FOR 2 WEEKS AND THEN FULL WEIGHT-BEARING DEPENDING ON THE DEGREE OF DISCOMFORT. THE PATIENT WAS FOLLOWED UP REGULARLY BY THE SURGEON IN CONSULTATION. THE METAL REMOVAL TOOK PLACE ON (B)(6) 2021. ALL LOCKING PINS WERE REMOVED THERE BUT THE NAIL COULD NOT BE TAKEN OUT DESPITE INTENSIVE EFFORTS. THE NAIL BOTHERED THE PATIENT AFTER 6 1/2 YEARS AND HE WANTED TO HAVE IT REMOVED. THE NAIL COULD NOT BE REMOVED DURING THE FOUR-HOUR SURGERY, WHICH UPSET THE PATIENT VERY MUCH. THE CUSTOMER SUSPECTS THAT THE NAIL BENT IN THE LOWER PART AND THEREFORE COULD NOT BE REMOVED."

  Patient problems: Discomfort

  MAUDE report 13737018 ↗