The pin driver, intended for use in treatment, was returned for investigation.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.There were no indications of an issue that would potentially lead to a future performance issue.A complaint history review found similar reports, this issue will continue to be monitored.We were not able to confirm if there was a relationship established between the reported event and the device.Visual and functional evaluation found the pin drivers worked as expected and had no damage.No problem found with the pin drivers.A factor that could have contributed to the reported issue is if the pin driver was not properly put onto the bone screw, causing it to be loose and appear stripped.No correction or corrective actions required at this time.
|