Tornier Latitude 9030394Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00846832020089), received between Feb 2, 2024 and Jul 31, 2026 — classified as 1 injury, 5 malfunctions.

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

• MalfunctionJul 31, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104768 ↗
• MalfunctionMay 13, 2026Fracture

  IT WAS REPORTED THAT, THE DISTAL END OF THE 5MM REAMER SEPARATED AFTER THE REAMER WAS REMOVED FROM REAMING THE ULNAR CANAL. SURGEON PROCEEDED WITH THE CASE AND USED THE NEXT SIZED REAMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164944 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE LATITUDE EV KIT WAS USED. WHEN USING 2 OF THE FLEXIBLE REAMERS ON THE KIT THEY SNAPPED/BROKE AND THEREFORE WILL NEED REPLACING ON THE KIT. UPON REAMING OVER THE GUIDE WIRE WHEN REMOVING THE REAMER 1 HAD SNAPPED IN HALF, THE SECOND HAD SNAPPED BUT DID NOT COME APART. BOTH REAMERS WERE REMOVED SUCCESSFULLY INCLUDING LOOSE ITEMS DUE TO THE BALL TIPPED WIRE AND NOTHING WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT, THE REAMERS WERE FINISHED WITH SO NOT NEEDED AGAIN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408221 ↗
• MalfunctionMay 27, 2025Break; Fracture; Material Twisted/Bent; Break; Fracture; Material Twisted/Bent

  DURING PRIMARY RIGHT TOTAL ELBOW REPLACEMENT, SEVERAL ISSUES AROSE REGARDING LATITUDE EV INSTRUMENT MALFUNCTION. 1. DURING INITIAL PREPARATION OF THE ULNAR, THE ULNAR JIG, RIGHT WAS FITTED IN PLACE AS PER THE SURGICAL TECHNIQUE. THE LARGE SIZING HUMERAL SPOOL WAS SLID OVER THE CENTRAL AXEL OF THE JIG, AND THE LARGE BELLSAW WAS THEN PLACED OVER THE SPOOL, IN PREPARATION FOR PROFILING THE PROXIMAL ULNAR. WHEN THE SURGEON ACTIVATED THE DRILL-REAMER POWER TOOL, THE BELL SAW CENTRAL AXEL JAMMED WITHIN THE HOLLOW CENTRAL AXEL OF THE JIG. THE SURGEON WAS UNABLE TO ADVANCE THE BELLSAW, OR REMOVE IT, AS IT APPEARED THAT THE METAL SURFACES HAD JAMMED TOGETHER. THE JIG WAS FULLY LOOSENED, THE BELLSAW DETACHED FROM THE DRILL / REAMER POWER TOOL, AND THE JAMMED CONSTRUCT WAS REMOVED, CAREFULLY, FROM THE ELBOW JOINT. THE BELLSAW WAS THEN ABLE TO BE DETACHED FROM THE JIG. ON INSPECTION, THE INNER HOLLOW TUBE OF THE ULNAR JIG, RIGHT, APPEARED TO HAVE METAL FATIGUE, CAUSING THE CENTRAL AXEL OF THE BELLSAW TO JAM. THE SURGEON DECIDED TO USE THE ULNAR JIG, LEFT, FLIPPED IT OVER, POSITIONED IT IN PLACE, AND COMPLETED THE PROFILING OF THE PROXIMAL ULNAR, TO HIS SATISFACTION. NO FURTHER ISSUES WITH USIN

  Patient problems: Insufficient Information

  MAUDE report 22086760 ↗
• InjuryMar 1, 2024Break; Fracture; Break; Fracture

  DURING A SURGICAL PROCEDURE, THE #5 FLEXIBLE REAMER BROKE WHILE BEING USED ON A PATIENT'S ELBOW. BOTH PIECES OF THE REAMER WERE RETRIEVED, AND AN X-RAY WAS TAKEN, WHICH SHOWED NO ABNORMALITIES. THE ORIGINAL INTENDED PROCEDURE WAS THE REMOVAL OF HARDWARE FROM THE RIGHT ELBOW, INSERTION OF A CEMENT ANTIBIOTIC SPACER, IRRIGATION AND DEBRIDEMENT OF THE RIGHT ELBOW, AND BURSECTOMY OF THE OLECRANON BURSA. THE USER ENCOUNTERED PROBLEMS RELATED TO DEVICE FAILURE AND MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 18822873 ↗
• MalfunctionFeb 2, 2024

  DURING THE SURGICAL PROCEDURE, THE #5 FLEXIBLE REAMER WAS BROKEN WHILE UTILIZING THE INSTRUMENT ON PATIENTS ELBOW. BOTH PIECES OF REAMER OBTAINED. X-RAY OBTAINED. RADIOLOGIST SPOKE TO ATTENDING PHYSICIAN - X-RAY NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629335 ↗