|
Model Number 72201518 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Information (3190)
|
Event Date 08/10/2020 |
Event Type
Injury
|
Event Description
|
It was reported that, during a wrist arthroscopic surgery using a "2.9mm abrader blade", metal pieces were found while removing the sclerotic bone.Although a back-up device was available to complete the procedure, it is unknown if there was a surgery delay.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
|
Event Description
|
It was reported that, during a wrist arthroscopic surgery using a "2.9mm abrader blade", metal pieces were found while removing the sclerotic bone.The metallic pieces were successfully removed from the patient.The pieces were removed using tweezers and suction.The procedure was completed using a back-up device.It is unknown if there was a delay.No other complications were reported.
|
|
Manufacturer Narrative
|
Event description updated.
|
|
Manufacturer Narrative
|
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A review of the instructions for use found: do not resterilize.For single use only.Discard any open, unused product.Do not use after the expiration date do not allow the rotating portion of any blade or burr to touch any metallic object such as a cannula or arthroscope.Damage to both instruments is likely.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.A review of risk management files found that the reported failure was documented appropriately.A review of the customer provided images show the packaging and confirms part number and lot number.Also shows a metal material from a scopes view.The complaint was confirmed.Factors that could have contributed to the reported event include side-loading.No containment or corrective actions are recommended at this time.
|
|
Search Alerts/Recalls
|
|
|