|
Catalog Number V040252025025 |
Device Problem
Break (1069)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Type
malfunction
|
Manufacturer Narrative
|
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The returned reciproc blue file is actually broken at the base of the active part (fatigue).No material defect was found during analysis of the rupture pattern.No unused file is available for evaluation.Nothing unusual to report was found during dhrs review.Root causes are not identified.We will track this kind of event and monitor the trend.For information, we remind the practitioner has to make sure that a straight-line access is created prior using the reciproc blue files (as mentioned in the dfu).
|
|
Event Description
|
In this event it was reported that one reciproc blue files broke during use.No patient injury so far.Fragment still remains in canal.The outcome of the event is unknown as of this mdr evaluation.
|
|
Manufacturer Narrative
|
The returned reciproc blue file r25 8/100 25mm 025 is actually broken at the base of the active part (fatigue).No material defect was found during analysis of the rupture pattern.No unused file is available for evaluation.Nothing unusual to report was found during dhrs review (batches #1672901, #1671971, #1671563, #1670766, #1673892, #1673604, #1673271 and #1673290.Root causes are not identified.We will track this kind of event and monitor the trend.
|
|
Search Alerts/Recalls
|
|
|