T2 1832-1045SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540515421), received between Nov 19, 2019 and Dec 23, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 41 HAD DEVICE REVISION OR REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23877168 ↗
• InjuryDec 22, 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 (B)(6) 2016 ¿ (B)(6) 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 21 HAD DELAYED UNION.

  Patient problems: Impaired Healing

  MAUDE report 23865860 ↗
• InjuryOct 29, 2025Malposition of Device; Malposition of Device

  AS REPORTED: "THE MOST PROXIMAL SCREW WAS UNABLE TO PASS THROUGH THE NAIL AND BECAME STUCK. THIS SCREW WAS NOT INSERTED, LEAVING THE BONE TUNNEL OPEN."

  Patient problems: Perforation

  MAUDE report 23418096 ↗
• MalfunctionOct 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF (T2 PHN) FOR RIGHT HUMERUS FRACTURE ON (B)(6) 2025. SCREW LOOSENING WAS OBSERVED AT POSTOPERATIVE FOLLOW-UP AND A REVISION SURGERY TOOK PLACE. THE SCREW WAS REINSERTED IN THE REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23336716 ↗
• 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, WOUND INFECTION WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.

  Patient problems: Wound Infection

  MAUDE report 19956401 ↗
• InjuryNov 19, 2019Break; Break

  AFTER THE PRIMARY SURGERY IN (B)(6) 2018, THE SCREW WAS GOING TO BE REMOVED ON (B)(6) 2019. AT THE TIME OF REMOVAL OF THE SCREW, THE SURGEON FORGOT TO TAKE OUT THE END CAP ON SCREW. THEREFORE, THE SCREW WAS OVERLOADED AND BROKE DURING REMOVAL. SINCE THERE WAS NO INSTRUMENT FOR BROKEN SCREW, IT WAS CLOSED AS IT WAS. THE REVISION SURGERY WILL BE RESCHEDULED.

  Patient problems: No Code Available

  MAUDE report 9341337 ↗