NA 0277010212Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540050496), received between Feb 20, 2023 and Oct 28, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Fracture; Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399926 ↗
• MalfunctionFeb 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT A CUSTOMER SITE, IT WAS NOTED THAT TWO BURS WERE BROKEN. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY, NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. THIS REPORT IS FOR THE SECOND BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404048 ↗
• MalfunctionFeb 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING INCOMING INSPECTION AT A CUSTOMER SITE, IT WAS NOTED THAT TWO BURS WERE BROKEN. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY, NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404002 ↗