T2 1847-1136SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613153316961), received between Jul 23, 2018 and Aug 23, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryAug 23, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE PATIENT THAT: "ON (B)(6) 2021 I SUFFERED A FRACTURE OF THE FEMUR IN A SKIING ACCIDENT. THIS WAS SURGICALLY STRAIGHTENED AT THE HOSPITAL IN LIENZ (AUSTRIA) AND THE FRACTURE WAS TREATED WITH A STRYKER NAILING SYSTEM (RECON 11/360). AFTER A LONG RECOVERY (HOSPITAL, REHAB AND PHYSIOTHERAPY ETC.) THE ABOVE MENTIONED INTRAMEDULLARY NAIL BROKE ON (B)(6) 2022. I FELT VERY STRONG PAIN IN THE RIGHT THIGH AND HIP. THE FRACTURE OF THE INTRAMEDULLARY NAIL WAS DIAGNOSED AT THE HOSPITAL AND IT WAS REMOVED DURING ANOTHER SURGERY ON (B)(6) 2022 AND REPLACED BY A NEW NAIL SYSTEM. THIS WAS FOLLOWED BY ANOTHER HOSPITAL STAY AND A NEW REHA IN BAD TABARZ IS STILL PENDING. MY NEW OPERATION CAUSED VERY SEVERE PAIN, WHICH CONTINUES TO THIS DAY. ACCORDING TO THE DOCTORS, THE SITUATION WILL NOT CHANGE FOR THE TIME BEING."

  Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 15280304 ↗
• InjuryJul 23, 2018Break

  THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP (PMCF) FROM (B)(6) HOSPITAL (B)(6). THE TITLE OF THIS REPORT IS ¿ANALYSIS OF THE T2 RECON NAIL USED WITH THE ANTEGRADE LOCKING MODE¿ WHICH WAS RELEASED IN JUNE 2018 AND IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM. WITHIN THAT REPORT, POSTOPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN JANUARY 2014 AND NOVEMBER 2017. BASED ON THE AVAILABLE DEVICE AND PATIENT INFORMATION AND A REVIEW OF COMPLAINT HANDLING DATABASE IT WAS REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE REPORT, THEREFORE 15 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE JOURNAL. THIS PRODUCT INQUIRY ADDRESSES SEPTIC NONUNION DISCOVERED FROM THE EVENT OF CASE ID (B)(6). ONE OUT OF 1 CASE. THE PMCFR STATES: ¿IN THE SECOND CASE (CASE (B)(6)) IT WAS A TRANSVERSE FRACTURE (32-A) IN A HEAVY (B)(6) YEARS LADY. SHE IS 1,63 M IN HEIGHT FOR A WEIGHT OF (B)(6) KG (BMI OF (B)(6)). THE BREAKAGE OF ALL THREE LOCKING SCREWS WAS OBSERVED. IN FACT A SEPTIC NONUNION WAS OBSERVED AND A REVISION SURGERY WAS PERFORMED 142 DAYS AFTER THE INITIAL SURGERY. ALL THE B

  Patient problems: Nonunion/Delayed-union Bone Fracture; Sepsis

  MAUDE report 7710742 ↗
• InjuryJul 23, 2018Break

  THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP (PMCF) FROM (B)(6). THE TITLE OF THIS REPORT IS ¿ANALYSIS OF THE T2 RECON NAIL USED WITH THE ANTEGRADE LOCKING MODE¿ WHICH WAS RELEASED IN JUNE 2018 AND IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM. WITHIN THAT REPORT, POSTOPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN JANUARY 2014 AND NOVEMBER 2017. BASED ON THE AVAILABLE DEVICE AND PATIENT INFORMATION AND A REVIEW OF COMPLAINT HANDLING DATABASE IT WAS REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE REPORT, THEREFORE 15 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE JOURNAL. THIS PRODUCT INQUIRY ADDRESSES IMPLANT BREAKAGE. TWO (CASE ID 62) OUT OF 3 CASES. THE PMCFR STATES: ¿IN 3 CASES (CASE 20,62 AND 71) BREAKAGE OF THE MATERIAL OCCURRED. THE BREAKAGE WAS SITUATED ON THE LOCKING SCREWS AND NEVER ON THE NAIL ITSELF. IN THE SECOND CASE (CASE 62) IT WAS A TRANSVERSE FRACTURE (32-A) IN A HEAVY 70 YEARS LADY. SHE IS 1,63M IN HEIGHT FOR A WEIGHT OF (B)(6). THE BREAKAGE OF ALL THREE LOCKING SCREWS WAS OBSERVED. IN FACT A SEPTIC NONUNION WAS OBSERVED AND A REVIS

  Patient problems: No Code Available

  MAUDE report 7710515 ↗