Medtronic Reusable Instruments 3990004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169091474), received between Oct 7, 2021 and Mar 2, 2026 — classified as 3 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL PROCEDURE. IT WAS REPORTED THAT THE SHAFT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED R EGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480239 ↗
• MalfunctionDec 20, 2021Scratched Material; Scratched Material

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR KYPHOSIS. PROCEDURE OR TECHNIQUE USED WAS PLIF. LEVELS IMPLANTED L4/5. IT WAS REPORTED THAT THE SURGEON CHOOSE A CAGE OF A NO PROBLEM SIZE WITH THE TRIAL, BUT WHEN THEY INSERTED THE CAGE, THEY COULD NOT TURN THE INSERTER. ONCE THE SURGEON PULLED OUT THE INSERTER, CAGE WAS TWISTED. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE CAGE WAS TWISTED. INSERTER TIPS WAS SLIGHTLY DEFORMED. SCRATCHES WERE FOUND AT THE TIP, THREADS NEAR THE HANDLE AND BOTTOM OF THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13041190 ↗
• MalfunctionOct 7, 2021Material Deformation; Material Deformation

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING L2-S2AI-PSF, L4/5-PLIF. THE PRE-OPERATIVE DIAGNOSIS WAS MENTIONED AS LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT, THE SHORT INSERTER WAS FOUND TO HAVE A CRACK AT THREAD AND THE OTHER INSERTER SHAFTS WERE NOT ATTACHED TO IMPLANT DUE TO THREAD DAMAGE. THE INSERTER TIP WAS DEFORMED. THE INSERTER SHAFT WAS STRIPPED AT THE TIP AND SCRATCHES AND BURRS WERE FOUND AT THREADS ON HANDLE SIDE. THE OTHER INSERTER HAD SCRATCHES AT TIP THREADS AND SCRATCHES AND STRIPPING FOUND AT THREADS. THE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT OF THIS EVENT. PATIENT MEDICAL HISTORY INCLUDES HT, DM, CEREBRAL INFARCTION, TWO-SIDED TKA, DVT. THERE WAS NO HEALTH DAMAGE IN PATIENT REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12588964 ↗