NA 1806-6162Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540510006), received between Jan 9, 2023 and Jan 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequate Instructions for Healthcare Professional” (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.

• MalfunctionJan 9, 2023Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  AS REPORTED: "ACCORDING TO OUR EXTRACTION INSTRUCTIONS, BROKEN GAMMA3 NAILS CAN BE REMOVED WITH A LARGE EXTRACTION HOOK. BASED ON THIS INFORMATION, THE CUSTOMER ORDERED A LARGE HOOK FOR NAIL REMOVAL. DURING THE SURGERY, IT WAS DISCOVERED THAT THE INFORMATION IN THE BROCHURE WAS INCORRECT AND THE EXTRACTION HOOK DID NOT FIT INTO THE NAIL. FOR THIS REASON, THE DURATION OF THE OPERATION WAS EXTENDED BY ONE HOUR AND THE REMOVAL OF THE NAIL HAD TO BE PERFORMED USING AN ALTERNATIVE METHOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128163 ↗