XIA 03807008Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327262452), received between Mar 7, 2016 and Jan 10, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT; THE SET SCREW WAS TIGHTENED WITH UNIVERSAL TIGHTENER, THE TIP OF THE TIGHTENER WAS BROKEN. THEREFORE, IT WAS CHANGED TO A NEW ONE AND THE SET SCREW WAS TIGHTENED.

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

  MAUDE report 7180047 ↗
• MalfunctionOct 17, 2016Break

  IT WAS REPORTED THAT; BLOCKER INSERT'S TIP WAS BROKEN DURING THE SURGERY AT HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH SPARE BLOCKER INSERTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6035027 ↗
• MalfunctionMar 7, 2016Fracture; Break; Fracture; Difficult to Remove

  IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON USED A TORQUE WRENCH AND A TIGHTENER FOR FINAL TIGHTENING OF A BLOCKER. THE TIP OF THE TIGHTENER WAS BROKEN. THE SURGEON COULD NOT REMOVE THE FRAGMENT OF THE TIGHTENER FROM THE BLOCKER. THE SURGEON TRIED TO TIGHTEN UP THE BLOCKER BY A COUNTER USING TWO DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5484956 ↗