|
Model Number 1883672HS |
Device Problem
Break (1069)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 11/28/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The burs were discarded by the customer.Therefore, a product analysis will not be performed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that intraoperative, the bur started to feel loose after approximately 30-45 minutes of drilling.This happened with three burs within the same case.In each instance, the surgeon stopped drilling and the device was removed from the patient.Outside of the patient, the burs were visually inspected.They noticed the burs were starting to come apart.After touching the tip during the visual inspection, the tip fell off.This took place away from the patient.Each time the surgeon was able to remove and replace the bur to complete the surgery.There was no patient injury.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|