NA 03.113.026Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982072924), received between Jul 30, 2019 and Jul 30, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction 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. 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.

• MalfunctionJul 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED ON (B)(6) 2019, ONE (1) INSERTION HANDLE FOR LOW BEND MEDIAL TIBIAL PLATE RIGHT WAS MISSING THE CONNECTING SCREW OR THE AIMING ARM. IT WAS ALSO MENTIONED THAT THE RAD TECH TRIED TO REMOVE THE CONNECTING SCREW FROM ONE (1) INSERTION HANDLE FOR LOW BEND MEDIAL TIBIAL PLATE WHICH WAS THE LEFT ONE TRYING TO PUT IT IN THE RIGHT ONE AND UPON THE CONNECTING SCREW WAS CROSS-THREADED WITH THE INSERTION HANDLE. LASTLY, ONE (1) STAR DRIVE SCREWDRIVER WAS DAMAGED WHILE TRYING TO REMOVE THE CONNECTING SCREW. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8843680 ↗