Catalog Number V041079000000 |
Device Problems
Failure to Align (2522); Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
In this event it has been reported that contra angle wont hold files.No treatment possible.Therefore no injury occured.
|
|
Manufacturer Narrative
|
There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
|
|
Manufacturer Narrative
|
There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
|
|
Event Description
|
In this event it has been reported that contra angle wont hold files.No treatment possible.Therefore no injury occured.
|
|
Manufacturer Narrative
|
Evaluation found a contra angle collet defect.
|
|
Search Alerts/Recalls
|