XIA ELEGANCE 482397028Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327275711), received between Dec 17, 2019 and Dec 17, 2019 — classified as 1 malfunction.

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.

• MalfunctionDec 17, 2019Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT A XIA 3 TITANIUM TORQUE WRENCH SHORT TIP FRACTURED DURING FINAL TIGHTENING. THE FRACTURED PIECE WAS SUCCESSFULLY REMOVED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9482686 ↗