FERKEL 72202153Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010622327), received between Mar 12, 2020 and Mar 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ANKLE ARTHROSCOPY, THE TIP OF A FERKEL MICROFRACTURE PICK BROKE WITHIN THE PATIENT'S BONE. AFTER PERFORMING X-RAYS EXAM, IT WAS DECIDED TO LEAVE THE FOREIGN BODY IN THE BONE AS REMOVING IT WOULD CAUSE MORE DAMAGE. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED, BUT THE SURGERY WAS NOT SIGNIFICANTLY DELAYED AS CONSEQUENCE OF THE ALLEGATION. THE PATIENT HAS RECOVERED SATISFACTORILY FROM THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9826361 ↗