na 7080911Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994236098), received between Jul 8, 2024 and Dec 11, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionDec 11, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER, TWO RATCHETING HANDLES, AWL WERE BROKEN. ALL INSTRUMENTS WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE. NO FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776313 ↗
• MalfunctionJan 25, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING AN AWL USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE AWL WAS BROKEN. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21236320 ↗
• MalfunctionJan 23, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A USER FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A FIXED ANGLE AWL USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN. TIP BROKE AFTER MANY USAGES. IT HAS BEEN USED IN PRIOR SURGERIES/ PROCEDURE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21215886 ↗
• MalfunctionJul 8, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690286 ↗