CONMED EL9101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20845854012793), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 malfunction.

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.

• MalfunctionApr 18, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, EL9101, 4.0MM OVAL BUR, EXTENDED LENGTH, (19CM), WAS BEING USED DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 23 WHEN IT WAS REPORTED, ¿WE WERE DOING A HIP ARTHROSCOPY. WHEN THE TIP OF THE SHAVER HE WAS USING BROKE OFF. THE TIP OF THE OVAL BURR BROKE OFF. SURGEON HAD TO STRUGGLE TO RETRIEVE SAID PIECE.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. AFTER THE INITIAL REPORT THE DISTRIBUTOR ALSO REPORTED THE INCIDENT BUT ADDED, ¿SURGEON RETRIEVED THE PIECE AND REMOVED OUT OF THE PATIENT¿, SO IT WAS ASSURED THAT THE FRAGMENTATION WAS RETRIEVED. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED WITH A 5-MINUTE DELAY USING AN ALTERNATE SAME-LIKE DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16760448 ↗