|
Model Number N/A |
Device Problems
Mechanical Problem (1384); Noise, Audible (3273)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
This event has been recorded by zimmer biomet under (b)(4).(b)(6).Report source: foreign: (b)(6).Investigation is complete.This is an initial final report submission.Review of the most recent repair record determined the unit was confirmed to make abnormal noise and was not functioning properly.The motor speed was unstable and the cable had contact issues; however, the repair was not completed because the customer requested the unit be scrapped.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.
|
|
Event Description
|
It was reported that dermatome had an abnormal noise and abnormal operation.No harm or injury reported.At product evaluation investigation the dermatome motor speed was found to be unstable.No adverse events were reported as a result of this malfunction.No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|
|
|