EVOS 72440807Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556646960), received between Aug 16, 2021 and Dec 12, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K162078, K210837); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE EVOS 3.5 MM 1/3 TUBULAR PL 7H 82MM BROKE INTO TWO PIECES. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023 IN WHICH THE DEVICE WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18314844 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A 3 MONTH FOLLOW UP AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED, THE PATIENT WAS EXPERIMENTING SOME PAIN. THE PATIENT WAS ADDED TO THE WAITING LIST FOR REVISION SURGERY TO ADDRESS THIS ADVERSE EVENT. PRIMARY FRACTURE FIXATION SURGERY WAS PERFORMED DUE TO A FIBULA FRACTURE AND THE UNION/CORRECTION PROCESS WAS ACHIEVED IN 3 MONTHS. THIS INFORMATION WAS COLLECTED FROM A POST-MARKET DATA COLLECTION ACTIVITY. THE DATA IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Pain

  MAUDE report 12329288 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 12 MONTH FOLLOW UP AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED, THERE WAS STILL NON-UNION. THE PATIENT ALSO REPORTED LIMITED FUNCTIONAL IMPAIRMENT AND EXTENSIVE PAIN. NO MEDICAL INTERVENTION WAS PERFORMED TO ADDRESS THIS ADVERSE EVENT. THIS INFORMATION WAS COLLECTED FROM A POST-MARKET DATA COLLECTION ACTIVITY. THE DATA IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Loss of Range of Motion; Malunion of Bone; Pain

  MAUDE report 12329286 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078, K210837. 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.