Model Number N/A |
Device Problems
Failure to Cut (2587); Output below Specifications (3004)
|
Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/20/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
This event has been recorded by zimmer biomet under cmp-(b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.Telephone number: (b)(6).
|
|
Event Description
|
It was reported that the device has low speed and appears to not evenly take skin after surgery.No additional skin graft was needed.No adverse events were reported as a result of this malfunction.
|
|
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 that the motor did not run smoothly and the depth bar had side play.The unit was recalibrated and the motor was 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
|