NA ARS743000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00846832068883), received between Jun 21, 2024 and Jul 2, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Mechanical Jam

  AS REPORTED: "THE HRS BROACH HANDLE WAS STUCK TO THE TRIAL WHILE IN THE HUMERUS. DOCTOR COULD NOT GET IT UNSTUCK EVEN WITH THE HANDLE OPEN AND TRIED MULTIPLE TIMES. THE DOCTOR WAS CONCERNED ABOUT PATIENT SAFETY AND POSSIBLE DISTAL HUMERUS FRACTURE FROM TRYING TO REMOVE BROACH HANDLE. IT DELAYED THE CASE DURING AND WE HAD TO USE AN OSTEOTOME TO HIT THE BROACH HANDLE OFF WHICH THE SURGEON CLAIMED WAS DANGEROUS AND AFFECTED PATIENT SAFETY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25692201 ↗
• 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 23927928 ↗
• 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 23708915 ↗
• MalfunctionAug 21, 2025Break; Degraded; Fracture; Break; Degraded; Fracture

  THE INSTRUMENT BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22863008 ↗
• MalfunctionJun 4, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  STICKY REVIVE / HRS HANDLES. PROXIMAL BODY TRIAL IS STICKING TO THE HANDLE AFTER BEING DISENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145534 ↗
• MalfunctionDec 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REP STATES "ATTACHMENT ON BROACH HANDLE IS LOOSE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873011 ↗
• MalfunctionDec 2, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "VERSION ROD BROKE OFF IN HOLE OF REVIVE INSERTER HANDLE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825270 ↗
• MalfunctionOct 15, 2024Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT A RETAINING PIN IN THE EXTRACTOR HANDLE WAS FOUND TO BE MISSING DURING SET INSPECTION, RENDERING THE INSTRUMENT UNUSABLE. THERE WAS NO ASSOCIATED SURGICAL CASE IMPACTED BY THIS ISSUE. THE INSTRUMENT, PART OF A CONSIGNMENT KIT, HAD BEEN HEAVILY USED, THOUGH SPECIFIC DETAILS REGARDING ITS TIME IN SERVICE OR THE NUMBER OF USES AND STERILIZATIONS WERE UNAVAILABLE. THE KIT HAD BEEN INSPECTED PRIOR TO BEING SENT OUT, AND THE INSTRUMENT HAS SINCE BEEN RETURNED FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456352 ↗
• MalfunctionJun 21, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THERE WAS AN INSTRUMENT BREAKAGE THAT OCCURRED DURING SET INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582168 ↗