XIA 3 48237028Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327265514), received between Apr 6, 2016 and Apr 1, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A XIA 3 TITANIUM TORQUE WRENCH BROKE INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13976688 ↗
• MalfunctionJan 18, 2019Break; Fracture; Detachment of Device or Device Component; Noise, Audible; Fracture

  IT WAS REPORTED THAT THE TORQUE WRENCH BROKE OFF INSIDE THE PATIENT WHILE TIGHTENING OF THE BLOCKER INTO ROD. A VERY AUDIBLE NOISE WAS HEARD WHEN IT BROKE OFF . THE SURGEON USED NEEDLE DRIVER TO RECOVER THE FRAGMENT PIECE THAT BROKE INSIDE THE PATIENT. A SURGICAL DELAY OF 10 MIN WAS REPORTED. A SURGERY WAS COMPLETED USING BACKUP TORQUE WRENCH. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8262558 ↗
• MalfunctionOct 3, 2018Break; Fracture; Detachment of Device or Device Component; Fracture

  IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE OFF USING THE T-HANDLE FINAL TIGHTENING TORQUE WRENCH. THE BROKEN FRAGMENT WAS RECOVERED FROM THE PATIENT INCISION AND THE SURGERY WAS COMPLETED WITH A BLOCKER INSERTER. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931886 ↗
• MalfunctionSep 28, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT TORQUE WRENCH FRACTURED AT THE DISTAL TIP WHEN FINAL TIGHTENING A BLOCKER , DURING AN ANTERIOR RELEASE WITH SCOLIOSIS CORRECTION PROCEDURE CARRIED OUT AT THE L2 LEVEL. THE DISTAL TIP OF THE TORQUE WRENCH BECAME LOOSENED FROM THE BLOCKER AND REMAINS IMPLANTED IN THE PATIENT. THE SURGEON DOES NOT SEE A NEED TO REMOVE IT AND IS NOT CONCERNED. BLOCKER WAS ASSUMED TO BE FINAL TIGHTENED. ANOTHER FINAL TORQUE WAS USED TO FINAL TIGHTEN THE REMAINING BLOCKERS SO THE SURGERY COULD BE COMPLETED. NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7918088 ↗
• MalfunctionAug 24, 2018Break; Fracture; Fracture

  TORQUE WRENCH BROKE DURING FINAL TIGHTENING OF BLOCKERS. BROKEN PARTS WERE TAKEN OUT BY SURGEONS WITH OSTEOTOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812569 ↗
• MalfunctionNov 21, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; TORQUE WRENCH BROKE WHEN BEING USED TO FINAL TIGHTEN SPINE CONSTRUCT. COUNTER TORQUE STANDARD INSTRUMENT WAS USED AS WELL. UPDATE 11/7/2017: TIP OF INSTRUMENT BROKE. ALL BROKEN FRAGMENTS WERE RETRIEVED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7049811 ↗
• MalfunctionMay 15, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE TORQUE WRENCH BROKE APART. THE TIP COULD WAS SCRAPPED BY CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6566704 ↗
• MalfunctionOct 31, 2016Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; DURING SURGERY, THE SURGEON USED THE TORQUE WRENCH AND ANTI TORQUE KEY FOR THE FINAL TIGHTENING OF THE BLOCKER. THE TIP OF TORQUE WRENCH WAS BROKEN. THE SURGEON REMOVED THE FRAGMENT OF THE TORQUE WRENCH FROM THE BLOCKER. THEREFORE THE SURGEON CHANGED THE TORQUE WRENCH TO ANOTHER TORQUE WRENCH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6068163 ↗
• MalfunctionApr 18, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS FINAL TORQUING THE BLOCKERS AND THE FINAL TORQUE BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5585661 ↗
• MalfunctionApr 6, 2016Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE TORQUE WRENCH BROKE DURING FINAL TIGHTENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5551836 ↗