XIA 3 48237056Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327265545), received between Dec 27, 2016 and Jun 27, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT WHILE TURNING THE ROD, THE ROTATION KEY AND FORCEPS BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ALTERNATE TOOLS IN THE SURGERY ROOM. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7642687 ↗
• MalfunctionDec 27, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT THE CLOSED HEX END BROKE DURING THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6205986 ↗