Tornier HRS ARS1023301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832094479), received between Dec 3, 2025 and Dec 30, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 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.

• MalfunctionDec 30, 2025Device Difficult to Setup or Prepare; Difficult to Remove; Device Difficult to Setup or Prepare; Difficult to Remove

  DURING INSPECTION OF INSTRUMENTS FROM A TRAY INTENDED FOR AN UPCOMING PROCEDURE, IT WAS NOTED THAT THE INSERTER HANDLE (ASR743000) ATTACHED TO THE TRIAL PROXIMAL BODY (ARS1023301) BUT DID NOT RELEASE AS INTENDED. WHEN THE LOCKING MECHANISM WAS FULLY DISENGAGED, THE TRIAL PROXIMAL BODY REMAINED FIXATED TO THE HANDLE. IT WAS SUSPECTED THAT THE HANDLE WAS FROM AN OLDER FLEX HRS SYSTEM RATHER THAN THE REWORKED HANDLE FOR THE PERFORM HUMERAL HRS SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23927924 ↗
• MalfunctionDec 3, 2025Difficult to Remove; Difficult to Remove

  THE NEW PROXIMAL BODIES FOR HRS ARE GETTING STUCK IN THE HANDLES. THE PHYSICIAN HAS TRIED AN OLD REVIVE HANDLE AND ORDERED A BRAND-NEW HANDLE. THE PROXIMAL BODIES HAVE GOTTEN STUCK ON MULTIPLE OCCASIONS AND CAUSED THEM TO HAVE TO TAP THE STEM OFF WITH A MALLET INTRA OP. SOMETIMES THE STEM COMES WITH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708913 ↗