|
Model Number N/A |
Device Problem
Failure to Power Up (1476)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/18/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.Review of the most recent repair record determined the corroded motor speed was unstable, the switch was not working properly, the cable was damaged (exposed wires), and the reciprocation arm was worn.The plug harness assembly, reciprocation arm, motor and switch were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If 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 for trends.G2: foreign: estonia.
|
|
Event Description
|
It was reported that outside of surgery, the electric dermatome does not react to switching on, the motor does not turn.There was no patient involvement.During device evaluation, it was discovered that the corroded motor speed was unstable, and the cable was damaged (exposed wires).Due diligence is complete, no further information is available.
|
|
Search Alerts/Recalls
|
|
|