Medtronic Reusable Instruments 5485930Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000572808), received between Jan 6, 2025 and Apr 3, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Mechanical Problem; Product Quality Problem; Mechanical Problem; Product Quality Problem

  INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR THE SPINAL THERAPY. IT WAS REPORTED THAT, UPON TESTING THE REDUCERS, PRIOR TO USE IN THE OPERATING ROOM, IT WAS FOUND THAT THE INNER SLEEVE DOES NOT REDUCE ENTIRELY. IT APPEARS THAT EITHER THE INNER SLEEVE GETS CAUGHT ON THE LIP OF THE OUTER REDUCER OR THE OUTER REDUCER HAS TOO NARROW OF AN OPENING FOR THE INNER REDUCER TO PASS THROUGH. THERE WAS NO PATIENT INVOLVED, NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759845 ↗
• MalfunctionJan 6, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING DEVICES USED FOR THORACOLUMBAR FUSIONS. IT WAS REPORTED THAT THE REDUCER WAS BROKEN, IT DOESN'T GRAB TO THE TULIPS HEADS. WHEN IT DOES GRAB, IT DOESN'T LET GO OF THE TULIP. ALSO, WHEN REDUCING, IT CATCHES AND DOESN'T WANT TO REDUCE. THE EXTENDER WAS BROKEN AS WELL. THEY ARE NOT FUNCTIONING HOW THEY SHOULD BE AND WERE NOT USABLE IN SURGERY. NO SURGEON USED THESE AND THEY WERE NOT USED IN A CASE. NO PATIENT WAS INVOLVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076872 ↗