T2 1832-3824SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540437143), received between May 4, 2021 and Dec 23, 2025 — classified as 6 injuries, 1 malfunction.

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

• InjuryDec 23, 2025Structural Problem; Structural Problem

  THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE T2 PROXIMAL HUMERAL NAILING (T2 PHN) IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF T2 PHN. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN 1 JAN 2016 ¿ 30 MAR 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT 3 HAD DEVICE REVISION OR REPLACEMENT AND STRUCTURAL PROBLEM.

  Patient problems: Insufficient Information

  MAUDE report 23878373 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE T2 PROXIMAL HUMERAL NAILING (T2 PHN) IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE", THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF T2 PHN. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN 1 JANUARY 2016 THROUGH 30 MARCH 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT 45 HAD LOSS OF RANGE OF MOTION.

  Patient problems: Loss of Range of Motion

  MAUDE report 23877760 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE T2 PROXIMAL HUMERAL NAILING (T2 PHN) IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF T2 PHN. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN 1 JAN 2016 ¿ 30 MAR 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT 59 HAD DEVICE REVISION OR REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23877325 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE T2 PROXIMAL HUMERAL NAILING (T2 PHN) IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF T2 PHN. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN 1 JAN 2016 ¿ 30 MAR 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT 52 HAD DEVICE REVISION OR REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23877320 ↗
• InjurySep 3, 2025Biocompatibility; Biocompatibility

  CUSTOMER SERVICE WAS CONTACTED BY A PATIENT INFORMING SHE HAS BEEN SUFFERING FROM SEVERE SKIN RASHES AND PAIN AFTER AN IMPLANT EMERGENCY SURGERY IN THE UPPER ARM AND REQUESTS SAMPLE OF THE COMPOSITION (METALS ETC) OF THE IMPLANTS AND SCREWS AS WELL AS A SAMPLE OF THE IMPLANTS SO THAT THE LAB/DERMATOLOGIST CAN DETERMINE WHETHER THE PARTS NEED TO BE REMOVED OR WHETHER THERE IS ANOTHER SOLUTION.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 22950339 ↗
• MalfunctionMar 12, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  AS REPORTED: "ORDERING ERROR BY SALES REP. A PROXIMAL HUMERAL LONG NAIL WAS INCORRECTLY ORDERED AND SHIPPED FOR A HUMERAL NAIL CASE. IT WAS USED WITHOUT BEING NOTICED AT THE SURGERY." NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887396 ↗
• InjuryMay 4, 2021Difficult to Remove; Difficult to Remove

  THE SURGEON REPORTED THAT NONE OF THE INSTRUMENTS ON THE METAL EXTRACTION FIT THE PROXIMAL HUMERAL NAIL. HE REPORTED THAT HE HAD ALREADY REMOVED THE TRANSVERSE SCREWS, BUT NEITHER THE EXTRACTION ROD NOR THE 6MM CONICAL ADAPTER WOULD GRAB THE PROXIMAL END OF THE NAIL. AS A RESULT, THE PROXIMAL HUMERUS WAS SPLIT TO LOOSEN THE NAIL. THERE WAS A 75 MINUTE SURGICAL DELAY AS A RESULT OF THE EVENT.

  Patient problems: Failure of Implant; Limb Fracture

  MAUDE report 11773329 ↗