N/A 4325Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403057137), received between Jul 6, 2020 and Jul 6, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT ARTHROGRAM TRAY HAD FOREIGN MATTER IN THE TRAY. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 4325 BATCH NO: 0001331662. IT WAS REPORTED THAT: DEBRIS FOUND IN STERILE ARTHROGRAM TRAYS ON TWO DIFFERENT INCIDENT DATES (6/1 AND 6/4). I HAVE RECEIVED TWO REPORTS OF STERILE ARTHROGRAM TRAYS NOT BEING STERILE UPON OPENING.

  Patient problems: No Patient Involvement

  MAUDE report 10236902 ↗
• MalfunctionJul 6, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT ARTHROGRAM TRAY HAD FOREIGN MATTER IN THE TRAY. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 4325 BATCH, NO: 0001331662. IT WAS REPORTED THAT: DEBRIS FOUND IN STERILE ARTHROGRAM TRAYS ON TWO DIFFERENT INCIDENT DATES (B)(6). I HAVE RECEIVED TWO REPORTS OF STERILE ARTHROGRAM TRAYS NOT BEING STERILE UPON OPENING.

  Patient problems: No Patient Involvement

  MAUDE report 10234260 ↗