Medtronic Reusable Instruments 8530630Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885074540702), received between Feb 8, 2025 and Mar 3, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionMar 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT INSTRUMENT BROKEN. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21502799 ↗
• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DRIVER SHAFT WAS BROKEN. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21443738 ↗
• MalfunctionFeb 21, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR LAMINO PLASTY. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21429667 ↗
• MalfunctionFeb 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN LAMINOPLASTY. IT WAS REPORTED THAT WHEN THE INSERTION OF THAT SCREW WAS STARTED UNDER A MICROSCOPE, IT WAS NOTICED THAT A SMALL PIECE OF METAL WAS ATTACHED TO THE SCREW HEAD, AND THAT SCREW WAS NOT USED. IT WAS REPLACED WITH A NEW SCREW OF THE SAME SIZE AND PLACED INSIDE THE PATIENT'S BODY. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS CERVICAL SPONDYLOTIC MYELOPATHY. THE LEVEL AT WHICH THE IMPLANT WAS PERFORMED: C3/6. THERE WAS A DELAY OF LESS THAN 60 MINUTES. THERE WAS NO PATIENT SYMPTOM IN THE EVENT AND NO FURTHER COMPLICATIONS/SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE THERE IS A POSSIBILITY THAT THE METAL FRAGMENT IS PART OF THE DRIVER. WHEN ATTACHED TO THE SCREW DRIVER AND CARRIED TO THE SURGICAL FIELD, A PIECE OF METAL WAS ATTACHED TO THE IMPLANT SCREW HEAD ON THE RIGHT SIDE OF THE SCREWDRIVER. THEREFORE, IT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340135 ↗
• MalfunctionFeb 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN LAMINOPLASTY. IT WAS REPORTED THAT WHEN THE INSERTION OF THAT SCREW WAS STARTED UNDER A MICROSCOPE, IT WAS NOTICED THAT A SMALL PIECE OF METAL WAS ATTACHED TO THE SCREW HEAD, AND THAT SCREW WAS NOT USED. IT WAS REPLACED WITH A NEW SCREW OF THE SAME SIZE AND PLACED INSIDE THE PATIENT'S BODY. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS CERVICAL SPONDYLOTIC MYELOPATHY. THE LEVEL AT WHICH THE IMPLANT WAS PERFORMED: C3/6. THERE WAS A DELAY OF LESS THAN 60 MINUTES. THERE WAS NO PATIENT SYMPTOM IN THE EVENT AND NO FURTHER COMPLICATIONS/SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE THERE IS A POSSIBILITY THAT THE METAL FRAGMENT IS PART OF THE DRIVER. WHEN ATTACHED TO THE SCREW DRIVER AND CARRIED TO THE SURGICAL FIELD, A PIECE OF METAL WAS ATTACHED TO THE IMPLANT SCREW HEAD ON THE RIGHT SIDE OF THE SCREWDRIVER. THEREFORE, IT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340132 ↗