NA 5400701000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540604101), received between Jan 29, 2019 and Oct 22, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Material Fragmentation; Material Fragmentation

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504464 ↗
• MalfunctionOct 23, 2023Material Fragmentation; Material Fragmentation

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986071 ↗
• MalfunctionOct 28, 2021Material Fragmentation; Material Fragmentation

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715291 ↗
• MalfunctionApr 24, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 20 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 20 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546026 ↗
• MalfunctionJan 29, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES <NOE> 5 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8285195 ↗
• MalfunctionJan 29, 2019Material Fragmentation; Material Fragmentation

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284615 ↗