XIA 3 48231330Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327265408), received between Mar 7, 2017 and Nov 21, 2018 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2018Loose or Intermittent Connection; Loose or Intermittent Connection; Connection Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING SURGERY SCREWDRIVER WAS NOT LOCKING PROPERLY AND FELT WOBBLY, WHILE LOADING FIRST SCREW. THE SCREWDRIVER WAS NOT ENGAGING PROPERLY WHILE LOADING THE SECOND SCREW . AT THE END OF PROCEDURE, UNABLE TO TAKE COMPONENTS OF ONE SCREWDRIVER APART. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP DEVICE. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8097785 ↗
• MalfunctionNov 21, 2018Mechanical Jam; Loose or Intermittent Connection; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY SCREWDRIVER WAS NOT LOCKING PROPERLY AND FELT WOBBLY, WHILE LOADING FIRST SCREW. THE SCREWDRIVER WAS NOT ENGAGING PROPERLY WHILE LOADING THE SECOND SCREW . AT THE END OF PROCEDURE, UNABLE TO TAKE COMPONENTS OF ONE SCREWDRIVER APART. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP DEVICE. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8097782 ↗
• MalfunctionMar 9, 2018Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT THE POLYAXIAL SHAFT BROKE OFF WHEN THE SURGEON WAS INSERTING THE SCREW ON POWER USING THE POWER ADAPTOR. THE SCRUB TECH WAS ABLE TO REMOVE THE BROKEN PIECE FROM THE POWER ADAPTOR. THE SURGEON WAS ABLE TO CONTINUE AND COMPLETE THE CASE WITH ANOTHER SHAFT. THERE WAS A FIVE MINUTE SURGICAL DELAY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7329009 ↗
• MalfunctionMar 7, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; INNER POLYAXIAL SCREW DIVER SHAFT BROKE NEAR THE PROXIMAL END.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6384167 ↗