CONMED 00509223200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854002940), received between May 22, 2018 and May 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 22, 2018Detachment Of Device Component; Detachment Of Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00509223200, 6.5 MM ROUND BUR, LONG, CARBIDE, 5EA, WAS BROKEN DURING USE BY A SURGEON ON (B)(6) 2018 WHILE CONDUCTING A HIP REPLACEMENT PROCEDURE. FRAGMENTS OF THE DEVICE FELL INTO THE SURGICAL SITE; HOWEVER, ALL WERE RETRIEVED USING TWEEZER/GRASPER. THERE WAS A REPORTED 15-MINUTE DELAY FOR AN X-RAY TO ASSURE RETRIEVAL OF ALL FRAGMENTS AND THEN THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO EXTENDED HOSPITAL STAY DUE TO THIS EVENT. THE STATUS OF THE PATIENT IS REPORTED AS NORMAL. IT WAS REPORTED THAT THERE WAS NO INJURY TO PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL OF INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7533476 ↗