RENOVATION 71369517Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010430137), received between Nov 13, 2019 and Aug 29, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionAug 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR PROCEDURE, THE TOP THE REVERSE CURETTE 7MM HANDLE BROKE. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15313174 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE REVERSE CURETTE 7MM HANDLE BROKE WHILE IT WAS BEING USED INSIDE THE PATIENT. NOTHING GOT INTO THE PATIENT. THERE WAS NO HARM TO THE PATIENT OR THE STAFF. THERE WAS NO PROCEDURAL DELAYS TO THE CASE. A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318649 ↗