Tornier Perform MWH744Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00846832071654), received between Apr 21, 2025 and Apr 21, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Break; Fracture; Break; Fracture

  DURING PRIMARY LEFT ANATOMIC SHOULDER REPLACEMENT, SURGEON WAS PREPARING THE GLENOID SURFACE TO RECEIVE A PERFORM + LEFT SMALL 15DEG POLY IMPLANT. PROCEDURE HAD PROCEEDED WITHOUT INCIDENT, UNTIL THE STEP TO UTILIZE THE KEELED OSTEOTOME AND PUNCH, WHICH ATTACHES ON TO THE HANDLE IN INSTRUMENTS. THE HANDLE WAS FOUND TO BE BROKEN. THE LOCKING SLEEVE WAS COMPLETELY SEPARATE TO THE MAIN HANDLE SHAFT. ATTEMPTS TO REATTACH THE SLEEVE ONTO THE HANDLE SO THE OSTEOTOME / PUNCH CAN BE LOCKED TO THE HANDLE, PROVED FRUITLESS. IN THE END, THE SURGEON FIRST PLACED THE OSTEOTOME (OVER THE GUIDE WIRE STILL INSITU) INTO THE SEMI-PREPARED "KEEL HOLE", THEN PLACED THE HANDLE ON TO THE END OF THE OSTEOTOME, AND IMPACTED THE OSTEOTOME. WITH THE HANDLE NOT ATTACHED TO THE OSTEOTOME, THE ONLY WAY TO REMOVE THE OSTEOTOME, WAS GRABBING IT WITH A PAIR OF HEAVY PLIERS, AND HITTING THE PLIERS WITH A MALLET TO BACK IT OUT. THIS PROCESS WAS REPEATED FOR THE PUNCH. THE SURGEON WAS HAPPY THAT THE KEEL-HOLE WAS ADEQUATELY PREPARED (THE TRIAL IMPLANT SEATED HOME FULLY WHEN INSERTED INTO THE GLENOID), BUT THE SURGEON WAS CONCERNED ABOUT POSSIBLE DAMAGE TO THE GLENOID SURFACE / VAULT, WHEN USING THE MALLET / PLIERS TO

  Patient problems: Insufficient Information

  MAUDE report 21878264 ↗