NULL 5108-127-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327303759), received between Dec 17, 2020 and Dec 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Vibration” (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 18, 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.

• InjuryDec 17, 2020Vibration; Vibration

  IT WAS REPORTED THAT DURING A TOTAL ANKLE REPLACEMENT PROCEDURE, WHILE THE SURGEON WAS MAKING A CUT, THE BLADE MOVED FROM SIDE TO SIDE MORE THAN NORMAL IN THE HANDPIECE SAW. IT WAS ALSO REPORTED THAT THE FIBULA WAS ACCIDENTALLY FRACTURED. IT WAS FURTHER REPORTED THAT THE SURGEON FIXED THE FRACTURE WITH A CANNULATED SCREW AND A PLATE. IT WAS FURTHER REPORTED THAT THERE WAS A 45 MINUTE DELAY AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 11031916 ↗