ZIMMER AIR DERMATOME

Description of Event or Problem

It was reported that during kit inspection, the device's burns theatre handpiece not working, the device needed a new blades and new tin. After final assessment, inconsistent speed was confirmed. There was no note of patient impact or delay. Due diligence is completed and there is no additional information available.

Additional Manufacturer Narrative

This complaint is recorded by Zimmer Biomet under (b)(4). Review of the most recent repair record determined the motor speeds were unstable, the swivel was loose, the width plates, machined head, and spring pin were damaged, the screws and actuator were worn, and the neckpiece, retaining ring, and spring seal were corroded. The screws, machined head, spring pin, neckpiece, retaining ring, spring seal, reciprocating arm, swivel, motor, and sleeve were replaced to resolve the reported issue. The width plates were returned as is. Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmedIf any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer Biomet will continue to monitor trends.G2: Foreign - Event occurred in United Kingdom.