MalfunctionHXL
SLOTTED MALLET
Received Aug 12, 2023 · Event occurred Jul 26, 2021
Report MW5143416 · MDR key 17536529
Device
Generic name
Mallet
Manufacturer
Zimmer BiometProduct problems
- Loose or Intermittent Connection
- Loose or Intermittent Connection
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS DISCOVERED TODAY - NOT IN SURGERY, JUST AT AN INSTRUMENT WAREHOUSE FACILITY THAT THIS MALLET IS NO LONGER USEFUL. THE BOND BETWEEN THE STEEL METAL MALLET AND ITS GRIP IS TOO LOOSE AND IT NEEDS TO BE REPLACED. ORIGINAL IMPLANT DATE NONE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).