EVOS 72463113Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556640432), received between Jan 3, 2019 and Oct 30, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY IN AN ATTEMPT TO LOCK A 55 MM, 3.5 LOCKING SCREW INTO A VA HOLE IN THE (72463113) 13 HOLE LEFT 3.5 LATERAL PROXIMAL TIBIA PLATE, THE SCREW POPPED RIGHT THROUGH THE VA HOLE. IT WAS OPTED TO FINISHED THE SCREW ON POWER THROUGH A MEDIAL EXIT HOLE IN THE PATIENT. A LARGER HEADED SCREW WAS USED TO REPLACE THE LOCKING SCREW. NO DELAY REPORTED.

  Patient problems: Rupture

  MAUDE report 9255854 ↗
• MalfunctionJan 3, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THERE WAS A STATIC THREADED HOLE THAT DISALLOWED A SCREW TO LOCK. SCREW TIGHTENED BY HAND. DELAY 0-30 MIN, HAD BACKUP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8214719 ↗
• MalfunctionJan 3, 2019Break; Fitting Problem; Break; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, ONE HOLE HAD VARIABLE ANGLE WHERE THE INNER TABS BROKE OFF WHILE THE SCREW WAS BEING INSERTED. SCREW WAS TIGHTENED BY HAND. DELAY 0-30MIN, SURGERY COMPLETED BY HAND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8214482 ↗