NA 1896-4026SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540202321), received between Dec 28, 2021 and Jun 6, 2022 — classified as 2 injuries.

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

• InjuryJun 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY THE ¿DEPARTMENT OF ORTHOPAEDIC HAND AND MICROSURGERY CENTER, OSAKA EKISAIKAI HOSPITAL, JAPAN¿. 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 F

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

  MAUDE report 14610153 ↗
• InjuryDec 28, 2021Migration; Migration

  IT WAS REPORTED THAT AFTER SURGERY OF THE T2 HUMERAL NAIL, THE MOST PROXIMAL AND MOST DISTAL SCREWS HAVE BACKED OUT. REVISION SURGERY IS PLANNED AT (B)(6) 2021. UPDATE 12/17/2021: REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 13102209 ↗