EVOS 72440808Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556640043), received between Aug 16, 2021 and Aug 8, 2024 — classified as 4 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K162078, 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.

• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A FIBULA ORIF PROCEDURE PERFORMED BEFORE OCTOBER 2020 TO REDUCE AN OBLIQUE LATERAL MALLEOLUS FRACTURE, ONE (1) PATIENT SUSTAINED AN INFECTION THAT REQUIRED THE REMOVAL OF ALL HARDWARE. THE FRACTURE WAS REPORTEDLY REDUCED AT SIXTEEN (16) POSTOPERATIVE WEEKS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 19945460 ↗
• InjurySep 9, 2021Break; Break

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION SURGERY PERFORMED ON (B)(6) 2021, THE EVOS 3.5MM 1/3 TUBULAR PL 8H 94MM BROKE OFF AT THE FRACTURE SITE. THIS ADVERSE EVENT LED TO A REVISION SURGERY, WHICH PERFORMED DATE IS UNKNOWN. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 12446856 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER 12 MONTH FOLLOW UP AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED, THE PATIENT WAS ADDED TO THE WAITING LIST FOR REVISION SURGERY DUE TO DECREASED ROM AND PAIN. PRIMARY FRACTURE FIXATION SURGERY WAS PERFORMED DUE TO A FIBULA FRACTURE AND THE UNION/CORRECTION PROCESS WAS ACHIEVED IN 12 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: Loss of Range of Motion; Pain

  MAUDE report 12329295 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, UPON 1.5 MONTH FOLLOW-UP AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A PROMINENT METALWORK. PRIMARY FRACTURE FIXATION SURGERY WAS PERFORMED DUE TO A FIBULA FRACTURE. 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: Discomfort

  MAUDE report 12329277 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078, 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.