EVOS 71177045Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556768112), received between Sep 15, 2022 and Sep 15, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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.

• InjurySep 15, 2022Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE USING THE EVOS SMALL LATERAL PROXIMAL TIBIA TARGETER SET, BOTH THE EVOS TGTR 2.5MM TPRD HEX DRVR SHAFT QC AND THE EVOS TGTR 2.5MM LINEAR HEX DRVR SHAFT QC STRIPPED THE SCREWS DURING INSERTION. THE FIRST OSTEOPENIA SCREW WAS DONE ON THE 2.5 TAPERED SHAFT, STARTING ON POWER, AND STRIPPING HALF WAY THOUGH INSERTION. THIS SCREW WAS REMOVED WITH PLIERS AND REPLACED WITH A 3.5 CORTEX SCREW. THAT 3.5 SCREW WAS INSERTED ON POWER, WITH SOME SUCCESS, BEFORE BEGINNING TO STRIP DURING FINAL HAND TIGHTENING. A SIMILAR SEQUENCE OCCURRED IN DISTAL HOLES OF PLATE. AFTER SEVERAL SCREWS, THE TEAM SWITCHED TO THE LINEAR DRIVER, WHICH WAS MORE SUCCESSFUL ON POWER, BUT STILL STRIPPED ON FINAL TIGHTENING. ADDITIONALLY, THE EVOS SMALL TGTR 3.5MM TROCAR CEASED TO FUNCTION PROPERLY AFTER FIRST USE. AFTER A SUCCESSFUL USE OF THE TROCAR, THE RING IN THE SHAFT THAT ALLOWS THE TROCAR TO RETAIN IN THE SCREW GUIDE BECAME MISALIGNED OR LOOSENED; HENCE, THE TROCAR COULD NOT BE FULLY INSERTED INTO THE SCREW GUIDE. THERE WAS ALSO A MISALIGNMENT AT 16H: 13H WAS TARGETED, BUT MISSED ON 16H. THE PROCEDURE WAS COMPLETED WITH THE SAME PRODUCTS AND/OR BACK-U

  Patient problems: Rupture

  MAUDE report 15426487 ↗