NA 7205334Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010251619), received between Apr 3, 2019 and Jun 27, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• InjuryJun 27, 2022Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, (2) SYNOVATOR PLATINUM BLADES BROKE WITHIN 5 MINUTES OF USE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14836416 ↗
• MalfunctionApr 3, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE DEVICE WAS LABELED AS A CONCAVE BLADE BUT IT WAS A CONVEX BLADE. THERE WERE NO SIGNIFICANT DELAY OR PATIENT INJURIES REPORTED. BACK UP DEVICE WAS USED IN ORDER TO COMPLETE THE PROCEDURE. THE WRONG DEVICE WAS USED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8479317 ↗