CONMED 00509124700Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854003169), received between Feb 17, 2023 and Feb 17, 2023 — classified as 1 injury.

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

• InjuryFeb 17, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE 00509124700, 1 X 19MM, WIRE PASS DRILL, MEDIUM, 5EA, WAS USED DURING A LE FORT I OSTEOTOMY ON THE DATE OF (B)(6)2022 WHEN IT WAS REPORTED, ¿WIRE PASS DRILL BIT (MEDIUM) FAILING DURING PROCEDURE (SMALL PORTION BROKE OFF ON THE FIELD).¿. AFTER FURTHER ASSESSMENT, IT WAS REPORTED, "WIRE PASS DRILL (MEDIUM) SMALL PORTION BROKE OFF ON FIELD. FIELD SEARCHED, FLOOR SEARCHED WITH MAGNET, X-RAY TAKEN. OBJECT NOT FOUND.". THERE WAS NO REPORT OF A DELAY, PATIENT OR USER IMPACT, PROLONGED HOSPITALIZATION OR MEDICAL INTERVENTION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO POSSIBLE FRAGMENTATION LEFT IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395494 ↗