INSTRUMENT 5511-T-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327207255), received between Jun 13, 2018 and Jun 13, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJun 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SURGEON THAT A CONDYLAR FRACTURE HAD OCCURRED AT SOME POINT DURING THE TOTAL KNEE PROCEDURE. IT WAS REPORTED THAT THE ORIGIN OF THE FRACTURE IS UNCLEAR. THE FRACTURE WAS REPORTED TO BE FIXED INTRA-OPERATIVELY WITH 2 CANCELLOUS SCREWS AND A FIBER-WIRE SUTURE. IT WAS REPORTED THAT THE ADDITIONAL TIME REQUIRED FOR THIS COMPLICATION WAS 20MIN.

  Patient problems: Bone Fracture(s)

  MAUDE report 7596629 ↗