EVOS 72424746Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556637500), received between Feb 18, 2020 and Feb 18, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K162078, K172262, K210837, K213126); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE THREAD PITCH ON THE 4.7MM FULLY THREADED OSTEOPENIA AND PARTIALLY THREADED OSTEOPENIA SCREWS ARE TOO AGGRESSIVE AND CAUSING A NUMBER OF ISSUES SUCH AS NOT BEING ABLE TO FIT THROUGH A PLATE HOLE OTHER THAN AT 90 DEGREES, THE THREAD CATCH THE PLATE, CAUSING THE PLATE TO LIFT OFF THE BONE DISPLACING/LOSING THE REDUCTION, THE FORCE TO ADVANCE THE SCREW CAUSING THE BONE FRAGMENT TO ROTATE AND MISALIGN WHICH ADDS A FURTHER OPERATION AS THE TENSION BAND WIRE NEEDS TO BE REMOVED, ALSO THE AMOUNT OF METAL EXCEEDS THE HOLE THE DRILL MAKES CAUSING THE BONE TO SPLIT.

  Patient problems: Injury

  MAUDE report 9722432 ↗
• InjuryFeb 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE THREAD PITCH ON THE 4.7MM FULLY THREADED OSTEOPENIA AND PARTIALLY THREADED OSTEOPENIA SCREWS ARE TOO AGGRESSIVE AND CAUSING A NUMBER OF ISSUES SUCH AS NOT BEING ABLE TO FIT THROUGH A PLATE HOLE OTHER THAN AT 90 DEGREES, THE THREAD CATCH THE PLATE, CAUSING THE PLATE TO LIFT OFF THE BONE DISPLACING/LOSING THE REDUCTION, THE FORCE TO ADVANCE THE SCREW CAUSING THE BONE FRAGMENT TO ROTATE AND MISALIGN WHICH ADDS A FURTHER OPERATION AS THE TENSION BAND WIRE NEEDS TO BE REMOVED, ALSO THE AMOUNT OF METAL EXCEEDS THE HOLE THE DRILL MAKES CAUSING THE BONE TO SPLIT.

  Patient problems: Injury

  MAUDE report 9722407 ↗
• InjuryFeb 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE THREAD PITCH ON THE 4.7MM FULLY THREADED OSTEOPENIA AND PARTIALLY THREADED OSTEOPENIA SCREWS ARE TOO AGGRESSIVE AND CAUSING A NUMBER OF ISSUES SUCH AS NOT BEING ABLE TO FIT THROUGH A PLATE HOLE OTHER THAN AT 90 DEGREES, THE THREAD CATCH THE PLATE, CAUSING THE PLATE TO LIFT OFF THE BONE DISPLACING/LOSING THE REDUCTION, THE FORCE TO ADVANCE THE SCREW CAUSING THE BONE FRAGMENT TO ROTATE AND MISSALIGN WHICH ADDS A FURTHER OPERATION AS THE TENSION BAND WIRE NEEDS TO BE REMOVED, ALSO THE AMOUNT OF METAL EXCEEDS THE HOLE THE DRILL MAKES CAUSING THE BONE TO SPLIT.

  Patient problems: Injury

  MAUDE report 9722404 ↗
• InjuryFeb 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE THREAD PITCH ON THE 4.7MM FULLY THREADED OSTEOPENIA AND PARTIALLY THREADED OSTEOPENIA SCREWS ARE TOO AGGRESSIVE AND CAUSING A NUMBER OF ISSUES SUCH AS NOT BEING ABLE TO FIT THROUGH A PLATE HOLE OTHER THAN AT 90 DEGREES, THE THREAD CATCH THE PLATE, CAUSING THE PLATE TO LIFT OFF THE BONE DISPLACING/LOSING THE REDUCTION, THE FORCE TO ADVANCE THE SCREW CAUSING THE BONE FRAGMENT TO ROTATE AND MISALIGN WHICH ADDS A FURTHER OPERATION AS THE TENSION BAND WIRE NEEDS TO BE REMOVED, ALSO THE AMOUNT OF METAL EXCEEDS THE HOLE THE DRILL MAKES CAUSING THE BONE TO SPLIT.

  Patient problems: Injury

  MAUDE report 9722401 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078, K172262, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-0265-2022 · Oct 25, 2021 · Open, Classified
  Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.