|
Device Problems
Vibration (1674); Failure to Cut (2587); Positioning Problem (3009)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/22/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during surgery there was a gap in between the blade and blade guard causing vibration and created a bad skin graft.The graft was not damaged.There was no patient harm or injury.There was no medical intervention, or and no additional surgery/graft procedure required.There was no surgical delay.Another device was used to complete the surgery.During device investigation, it was discovered that the dermatome may have attributed to the reported event.Due diligence is complete, no further information is available.
|
|
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot/serial identification are necessary for review of device history records, neither were provided.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.Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-00787-1 h3 other text : product not returned.
|
|
Search Alerts/Recalls
|
|
|