EVOS 72403520Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556634356), received between Dec 22, 2020 and Dec 22, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2020Break; Break

  IT WAS REPORTED THAT A SURGERY ON A PATIENT WITH A FRACTURED HUMERUS 7 WEEKS AGO HAPPENED. THE PHYSICIAN USED A 15 HOLE PROXIMAL HUMERUS PLATE WITH LOCKING SCREWS IN TO THE HEAD AND NON-LOCKING SCREWS DISTALLY. THE BONE PURCHASE WAS EXCELLENT. RECENTLY THE PATIENT EXPERIENCE SUDDEN PAIN. X-RAY IMAGES SHOW THAT THE HEADS OF THE DISTAL NON-LOCKING SCREWS APPEAR TO HAVE SHEERED RIGHT OFF, AND ONE PULLED OUT. IN TOTAL 4 SCREW WERE BROKEN. THE PHYSICIAN USED LOCKING SCREWS IN THE DISTAL HOLES AND ADDED 3 MORE SCREWS THAN INITIALLY IMPLANTED ON THE PRIMARY SURGERY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11060814 ↗
• InjuryDec 22, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT WITH A FRACTURED HUMERUS HAD SURGERY 7 WEEKS AGO. IN THE PROCEDURE, THE PHYSICIAN USED A 15 HOLE PROXIMAL HUMERUS PLATE WITH LOCKING SCREWS IN TO THE HEAD AND NON-LOCKING SCREWS DISTALLY. THE BONE PURCHASE WAS DESCRIBED AS EXCELLENT. RECENTLY, THE PATIENT EXPERIENCE SUDDEN PAIN. X-RAY IMAGES SHOWED THAT THE HEADS OF THE DISTAL NON-LOCKING SCREWS APPEARED TO HAVE BEEN SHEERED OFF AND ONE PULLED OUT. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11060775 ↗

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.