Catalog Number 6541-2-609 |
Device Problems
Break (1069); Nonstandard Device (1420)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 03/30/2015 |
Event Type
malfunction
|
Event Description
|
Upon routine inspection of the ankle clamp after sterile processing it was discovered that the clamp was broken.
|
|
Manufacturer Narrative
|
When completed, the investigation results will be submitted in a supplemental report.
|
|
Manufacturer Narrative
|
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there have been similar events for the reported lot.The reported event was confirmed.One of the flippers of the triathlon tibial alignment ankle clamp fractured.The device was manufactured to revision g of the product drawing.The damaged device was discovered during inspection; there was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
Upon routine inspection of the ankle clamp after sterile processing it was discovered that the clamp was broken.
|
|
Search Alerts/Recalls
|