T2 1832-1035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540515414), received between Jul 16, 2020 and May 11, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Positioning Failure

  DURING T2PH SURGERY, THE SCREW PLACED IN THE MOST DISTAL OVAL HOLE PROTRUDED ANTERIORLY BEYOND THE BONE. AS THE EVENT OCCURRED AFTER SCREW INSERTION INTO THE DISTAL ROUND HOLE, THE SCREW PLACED IN THE DISTAL OBLONG HOLE WAS REMOVED FROM THE BODY. SINCE ONE SCREW REMAINS INSERTED DISTALLY, THE PHYSICIAN ASSESSED THAT STABLE FIXATION HAD BEEN ACHIEVED. UPON INSPECTION OF THE TARGETING DEVICE AT THE JAPAN DISTRIBUTION CENTER, IT WAS CONFIRMED THAT THE DRILL INTERFERES WITH THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25138091 ↗
• 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 (B)(6) HAD IMPLANT PAIN.

  Patient problems: Implant Pain

  MAUDE report 23877529 ↗
• 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 (B)(6) HAD DEVICE REVISION OR REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23877317 ↗
• InjuryDec 22, 2025Migration; Migration

  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 47 HAD DEVICE DISPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23865853 ↗
• InjuryAug 15, 2023Migration; Migration

  AS REPORTED: "THE PROXIMAL SIDE OF THE DISTAL HUMERAL DIAPHYSEAL SCREW IS REPORTED BACKED OUT. THIS EVENT WAS CONFIRMED IN THE POSTOPERATIVE FOLLOW-UP. CURRENTLY, THE PATIENT IS SETTLED. REVISION SURGERY IS NOT PLANNED."

  Patient problems: Insufficient Information

  MAUDE report 17548910 ↗
• InjuryJun 6, 2022Material Twisted/Bent; Material Twisted/Bent

  THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF (B)(6) CENTER, (B)(6) HOSPITAL, (B)(6)¿. THE TITLE OF THIS REPORT IS, ¿EVALUATION OF INTRAMEDULLARY NAIL FIXATION VIA THE NEVIASER PORTAL FOR PROXIMAL HUMERUS FRACTURE¿ PUBLISHED ON FEBRUARY 08, 2019, WHICH IS ASSOCIATED WITH THE STRYKER ¿T2 PROXIMAL HUMERAL NAILING SYSTEM¿. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.1016/J.JCOT.2019.02.007. THIS REPORT INCLUDES AN ANALYSIS OF THE CLINICAL DATA THAT WAS COLLECTED ON 4 PATIENTS. THE CASES IN THIS STUDY RANGE FROM APRIL 2014 AND MARCH 2017. DURING THE REVIEW OF THE LITERATURE, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE. IT WAS REPORTED THAT 1 PATIENT EXPERIENCED PAIN, AND RESTRICTED RANGE OF MOTION (ROM) DUE TO FAILURE OF FIXATION WITH RECURRENT VARUS DEFORMITY AND SLIPPING OUT OF THE PROXIMAL INTERLOCKING SCREW. THE REPORT STATES, ¿IN THIS CASE, WE USED A BENT NAIL UNLIKE THE OTHER THREE CASES IN WHICH STRAIGHT NAILS WERE USED. WE CONSIDER THIS DIFFERENCE CAN BE A CAUSE OF THIS COMPLICATION. THIS PATIENT ALSO EXPERIENCED FAILURE OF FIXATION WITH RECURRENT V

  Patient problems: Deformity/ Disfigurement; Implant Pain; Loss of Range of Motion

  MAUDE report 14610035 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "A REVISION SURGERY USING A T2PH LONG NAIL AFTER T2PH SHORT NAIL REMOVAL FOR RE-FRACTURE OF A PATIENT WAS PERFORMED. THE PRIMARY SURGERY WAS PERFORMED 4 YEARS AGO."

  Patient problems: Limb Fracture

  MAUDE report 14102848 ↗
• InjuryDec 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HUMERUS WAS REVISED ONE DAY POST-IMPLANT DUE TO THE PROXIMAL ASPECT OF THE HUMERAL NAIL COMING OUT OF THE PROXIMAL HUMERUS. THE PATIENT'S HUMERAL FRACTURE WAS NOTED TO BE DISPLACED. IT IS NOT KNOWN IF AN INTRAOPERATIVE EVENT THE DAY PREVIOUS WAS A CAUSE OR CONTRIBUTOR TO THE FAILURE. REVISION PERFORMED, THE NAIL WAS REMOVED AND A HUMERAL PLATE WAS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12975105 ↗
• MalfunctionNov 3, 2021Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THE FOLLOWING: UPON ATTEMPTING EXPLANTATION, ONE OF THE DISTAL LOCKING PINS WAS FOUND TO BE COLD WELDED. THE BOLT HAD TO BE EXPOSED VENTRALLY AND DORSALLY AND MILLED OFF SO THAT THE NAIL COULD BE KNOCKED OUT OF THE MEDULLARY CANAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12743585 ↗
• InjuryJul 16, 2020Fracture; Fracture

  IT WAS REPORTED: AFTER FALLING,THE PATIENT RE-FRACTURED AND NAIL FRACTURED, AS WELL. REVISION SURGERY OCCURRED AS A RESULT.

  Patient problems: Failure of Implant; Fracture, Arm; Injury; Limb Fracture

  MAUDE report 10286540 ↗