FMS NEXTRA 283325Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705000074), received between Aug 8, 2018 and Aug 8, 2018 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING KNEE SURGERY SURGICAL PROCEDURE, IT WAS OBSERVED THAT A SMALL FRAGMENT FROM THE SHAVERBLADE BROKE OFF INTO THE JOINT. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO FETCH THE FRAGMENT, SO THE DOCTOR HAD TO LEAVE IT IN THE JOINT. IT WAS REPORTED THAT THE FRAGMENT WAS TINY ( 1X1 MM). IT WAS REPORTED THAT ONE OF THE TEETH ON THE OUTER SLEEVE WAS ON THE SHAVER BLADE. IT WAS REPORTED THAT NO X-RAY WAS PERFORMED. IT WAS REPORTED THAT IT WAS DECIDED QUICKLY THAT THE FRAGMENT WAS SO SMALL, AND SAFELY PLACED IN THE LATERAL RECESS OF THE KNEE. IT WAS REPORTED THAT THERE WON'T BE ANY RE-OPERATION; HOWEVER, IF IT WILL BE CONSIDERED IF THERE ARE ANY COMPLICATIONS. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7764301 ↗