NA 72200726Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010578044), received between Sep 25, 2020 and Nov 9, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Flaked” (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.

• InjuryNov 9, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A METAL SHAVINGS AND DEBRIS INTO THE PATIENT AND IT WAS SUCCESSFULLY REMOVED WITH SUCTION STRAIGHT AWAY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY WAS REPORTED WITH NO PATIENT COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10814569 ↗
• InjurySep 25, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ANKLE SCOPE, THE BURR LEFT METAL SHAVINGS IN THE PATIENT'S JOINT. THE RESIDUE WAS BURRED AWAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10587933 ↗
• InjurySep 25, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ELBOW SCOPE, THE BURR LEFT METAL SHAVINGS IN THE PATIENT'S JOINT. THE RESIDUE WAS BURRED AWAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10587916 ↗