Model Number N/A |
Device Problems
Component Falling (1105); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/31/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.It is unknown which tibial impactor was found missing a cushion or which one lost the cushion after opening the tray.Therefore, both devices are reported.This report is number 2 of 2 mdr's filed for the same event (reference 3002806535-2016-00545 & 00546).Return expected, not yet received.
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Event Description
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Upon opening an instrument case during a partial knee arthroplasty, the tibial impactor was found missing a cushion.The impactor was used without patient injury or delay in the procedure.A second tibial impactor's cushion fell off after the case was opened.No additional information has been provided.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.
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Search Alerts/Recalls
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