REUNION 5901-6072Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327293845), received between Jul 6, 2020 and Jul 6, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryJul 6, 2020Fracture; Fracture

  DURING THE REAMING PROCESS OF GLENOID FOR A CONVERSION OF A TOTAL SHOULDER TO A REVERSE. UPON REMOVING THE REAMER HANDLE FROM THE GLENOID THE NITINOL PILOT WIRE WAS MISSING FROM THE REAMER SHAFT. AN XRAY CONFIRMED THAT THE WIRE WAS LODGED IN THE POSTERIOR ASPECT OF THE SCAPULA WITH NO SIGN OF THE END OF WIRE FROM GLENOID PERSPECTIVE. DOCTOR WORKED ON TRYING TO RETRIEVE FROM THE GLENOID FOR SOMETIME TILL AN INCISION WAS MADE POSTERIOR SCAPULA TO RETRIEVE. THERE WAS ADDITIONAL TIME ADDED TO THE PROCEDURE. ALL IN TOTAL BETWEEN AN 90-120 MIN.

  Patient problems: Injury

  MAUDE report 10237062 ↗