HALL MICROFREE PRO8300SBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405005742), received between Dec 9, 2024 and Dec 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Material Separation; Material Separation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE PRO8300SB, HALL MICROFREE OSCILLATING SAW DEVICE WAS USED IN A FOOT AND ANKLE PROCEDURE ON (B)(6) 2024, AND THEY ¿HAD A RECIP SAW BREAK TODAY DURING SURGERY. PATIENT WASN¿T HARMED.¿. FURTHER ASSESSMENT FOUND THAT ALL FRAGMENTS WERE RETRIEVED FROM THE SURGICAL SITE, AND THE PROCEDURE WAS COMPLETED AS NORMAL WITH AN ALTERNATE DEVICE AND A DELAY OF ¿3 MINUTES FOR A NEW SAW¿. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879425 ↗