Medtronic Reusable Instruments 7967003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994321213), received between Dec 2, 2024 and Dec 2, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 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 TIP OF AWL BROKEN WHEN SURGEON WAS MAKING PILOT HOLES. NO FRAGMENT OF BROKEN AWL LEFT INSIDE PATIENT BODY. THE DRIVER WAS STRIPPED WHEN TRIED TO ADJUST THE PEDICLE SCREW. WHILE ADJUSTING THE GOLD NUT ON X10 CROSSLINK, THE INSTRUMENT WAS STRIPPED. P ROCEDURE/TECHNIQUE PERFORMED WAS ANTERIOR LUMBAR INTERBODY FUSION AND POSTERIOR LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20816850 ↗