Model Number 3.0MM DRILL BIT |
Device Problem
Fitting Problem (2183)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/14/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, evaluation reveals approximately.57 in of the flute broke off.Relevant features and material were found to meet drawing specifications.Abrasion marks were observed on the flute.A likely cause of the breakage is prying/leveraging the device during use.
|
|
Event Description
|
It was reported that during an inverse prosthesis surgery the device didn`t fit into the drill guide.No part of the device broke off.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.During returned device evaluation, a reportable malfunction was discovered.
|
|
Search Alerts/Recalls
|