|
Model Number N/A |
Device Problem
Failure to Cut (2587)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that outside of surgery the dermatome took an incomplete graft, leaving holes, strips in the graft.No report of patient harm or procedure delay.Due diligence is complete.There is no additional information available.At product evaluation investigation it was determined that the blade used could have contributed to the reported event of not cutting properly.No adverse events were reported as a result of this malfunction.
|
|
Manufacturer Narrative
|
This event has been recorded by zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01018-1 the investigation is complete.This is an initial final report submission.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.The event cannot be 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.H3 other text : device not returned.
|
|
Search Alerts/Recalls
|
|
|