XIA 03807028Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327262292), received between Sep 25, 2017 and Jun 18, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2021Fracture; Fracture

  IT WAS REPORTED THAT WHILE USING THE XIA LL TORQUE WRENCH TO LOCK THE NUT, THE TIP OF THE DEVICE FRACTURED. NO ADVERSE CONSEQUENCES, SURGICAL DELAY OR MEDICAL INTERVENTION WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING AN ALTERNATIVELY AVAILABLE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026116 ↗
• MalfunctionJul 25, 2019Fracture

  IT WAS REPORTED THAT WHEN THE SURGEON WENT TO LOCK THE NUT, THE TIP OF THE XIA II TITANIUM TORQUE WRENCH FRACTURED. THIS EVENT RESULTED IN A 15 MINUTE SURGICAL DELAY TO REMOVE THE BROKEN PART. THE DEVICE HAS BEEN IN USE APPROXIMATELY "7 YEARS AND USED AN ESTIMATED 700 TIMES." NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826448 ↗
• MalfunctionAug 29, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT BROKE OFF DURING SURGERY. NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7831430 ↗
• MalfunctionFeb 7, 2018Break

  IT WAS REPORTED THAT THE INNER SHAFT OF THE TORQUE WRENCH BROKE DURING THE FINAL TIGHTENING OF PEDICLE SCREWS AT THE L4-L5 LEVEL. THERE WAS A REPORTED DELAY OF MORE THAN 20 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE TORQUE WRENCH. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7249952 ↗
• MalfunctionSep 25, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; DURING TIGHTENING OF THE BLOCKER IN THE SCREW DURING A DORSALE STABILISATION THE TIP OF THE HEX DRIVERBROKE PRIOR REACHING THE 12 NM MARK.

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

  MAUDE report 6891826 ↗