|
Model Number N/A |
Device Problem
Failure to Cut (2587)
|
Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/01/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.
|
|
Event Description
|
It was reported that the dermatome was skipping during testing.There was no was no harm, delay unknown.
|
|
Manufacturer Narrative
|
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the device was out of calibration, head and control bar damaged, and head, control bar, and bearings replaced and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
|
|
Event Description
|
There is no additional information.
|
|
Search Alerts/Recalls
|
|
|