HALL MICROFREE PRO8400SBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653405005759), received between Apr 19, 2018 and Apr 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 19, 2018Connection Problem; Device Operational Issue; Connection Problem; Device Operational Issue

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING USE OF THE PRO8400SB, MICROFREE RECIPROCATING SAW, IN A FOOT SURGERY ON (B)(6) 2018, THAT THE DEVICE IT RELEASED THE CONCOMITANT DEVICE, (B)(4), MICRO RECIPROCATOR RASP, SMALL, CROSS CUT, INTO THE SURGICAL SITE. THE NURSE THEN REMOVED THE BLADE BY HAND FROM THE SURGICAL SITE. THERE WAS A 4 MINUTE DELAY IN PROCEDURE WHILE AN ALTERNATE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY WITH THIS REPORTED ISSUE AND THE PROCEDURE WAS OTHERWISE COMPLETED AS PLANNED. ADDITIONALLY, THE NURSE STATED THAT DURING ASSEMBLY OF THE BLADE AND THE SAW, THE BLADE APPEARED TO BE LOOSE. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH A POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7442837 ↗