CONMED 8204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854038918), received between Feb 20, 2019 and Mar 12, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE 8204, MICROFRACTURE AWL BROKE DURING A MICROFRACTURE PROCEDURE ON (B)(6) 2019. THE SURGEON WAS MAKING A HOLE USING A MALLET AND THE MICROFRACTURE AWL. WHILE TAPPING THE AWL THE TIP BROKE OFF INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED USING A MOSQUITO CLAMP. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A WIRE PIN. THERE WAS NO PATIENT INJURY AND A 1-MINUTE DELAY OF SURGERY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8412189 ↗
• MalfunctionFeb 20, 2019Break; Break

  THE CUSTOMER REPORTED THAT THE 8204, MICROFRACTURE AWL BROKE DURING A MICROFRACTURE PROCEDURE ON (B)(6) 2019. THE SURGEON WAS MAKING A HOLE USING A MALLET AND THE MICROFRACTURE AWL. WHILE TAPPING THE AWL THE TIP BROKE OFF INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED USING A MOSQUITO CLAMP. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A WIRE PIN. THERE WAS NO PATIENT INJURY AND A 1-MINUTE DELAY OF SURGERY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354851 ↗